FDA 510(k) Applications for Medical Device Product Code "FED"
(Endoscopic Access Overtube, Gastroenterology-Urology)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K082102 | APOLLO ENDOSURGERY, INC. | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | 06/14/2010 |
| K122270 | APOLLO ENDOSURGERY, INC. | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | 09/28/2012 |
| K990775 | APPLIED MEDICAL RESOURCES | URETERAL ACCESS SHEATH SET | 04/21/1999 |
| K993650 | APPLIED MEDICAL RESOURCES | URETERAL ACCESS SHEATH SET - NEW MODELS | 12/28/1999 |
| K030642 | APPLIED MEDICAL RESOURCES CORP. | DEFLECTING URETERAL ACCESS SHEATH | 05/23/2003 |
| K172575 | BAROnova, Inc. | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap | 01/18/2018 |
| K082589 | BAROSENSE, INC | BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 | 05/22/2009 |
| K120126 | BAROSENSE, INC | BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE | 09/10/2012 |
| K122565 | BODDINGTONS PLASTICS LTD | ARC ENDOCUFF | 09/04/2012 |
| K162205 | BODDINGTONS PLASTICS LTD | Arc EndoCuff and Arc EndoCuff Vision | 12/09/2016 |
| K191067 | Boddingtons Plastics Ltd | Arc Endocuff Glide AEG110 & AEG120 | 05/30/2019 |
| K151801 | BODDINGTONS PLASTICS LTD | Arc Endocuff Vision | 08/13/2015 |
| K140323 | BOSTON SCIENTIFIC | NAVIGATOR HD URETERAL ACCESS SHEATH SETS | 03/07/2014 |
| K173400 | Boston Scientific | ORISE Tissue Retractor System | 02/09/2018 |
| K122649 | BOSTON SCIENTIFIC CORP. | NAVIGATOR HD URETERAL ACCESS SHEATH SET | 12/12/2012 |
| K030956 | BOSTON SCIENTIFIC CORP. | NAVIGATOR URETERAL ACCESS SHEATH SET | 05/23/2003 |
| K051504 | BOSTON SCIENTIFIC CORP. | SPYSCOPE ACCESS AND DELIVERY CATHETER | 06/16/2005 |
| K250517 | Boston Scientific Corporation | NavigatorÖ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); NavigatorÖ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); NavigatorÖ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); NavigatorÖ HD Ureteral Access Sheath Set 1 | 03/21/2025 |
| K030438 | C.R. BARD, INC. | BARD AQUAGUIDE URETERAL CONDUIT | 03/17/2003 |
| K973500 | C.R. BARD, INC. | BARD ENDOSCOPIC OVERTUBE (#000307) | 10/16/1997 |
| K033778 | C.R. BARD, INC. | MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT | 12/30/2003 |
| K160861 | C.R. Bard, Inc. | Proxis Ureteral Access Sheath | 03/31/2016 |
| K150083 | C2 THERAPEUTICS | Sidecar External Working Channel | 04/14/2015 |
| K233472 | Calyxo, Inc. | CVAC Aspiration System + CVAC Image Processor | 02/02/2024 |
| K250585 | CatheGenix (Xiamen) Co., Ltd. | LumenaTM Ureteral Access Sheath | 06/27/2025 |
| K102485 | COLOPLAST A/S | RE-TRACE URETERAL ACCESS SHEATH | 10/18/2010 |
| K123675 | COLOPLAST A/S | RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR | 03/01/2013 |
| K140523 | COLOPLAST A/S | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | 07/24/2014 |
| K181811 | Coloplast A/S | ReTrace Ureteral Access Sheath | 09/07/2018 |
| K242173 | Coloplast Corp. | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | 11/12/2024 |
| K983415 | CONWAY STUART MEDICAL, INC. | DELIVERY SHEATH | 12/01/1998 |
| K172217 | Cook Incorporated | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath | 12/13/2017 |
| K182403 | Cook Incorporated | Peel-Away Introducer | 05/29/2019 |
| K043418 | COOK UROLOGICAL, INC. | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH | 03/31/2005 |
| K110531 | CROSPON, LTD. | ENDOFLIP ECD | 10/06/2011 |
| K241181 | Dongguan ZSR Biomedical technology Company Limited | Disposable Ureteral Guide Sheath | 08/02/2024 |
| K243820 | Dornier MedTech America | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | 01/31/2025 |
| K201815 | Dornier MedTech America Inc | Dornier MAGELLAN Ureteral Access Sheath | 11/20/2020 |
| K133359 | ENDO-AID, INC. | ENDORINGS | 02/11/2014 |
| K243091 | Fujifilm Corporation | Over-tube (TR-1108A) | 11/01/2024 |
| K230752 | Fujifilm Healthcare Americas Corporation | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | 09/15/2023 |
| K091773 | FUJINON, INC. | FUJINON STERILE OVERTUBES | 08/07/2009 |
| K192691 | H&A Mui Enterprises Inc. | PatCom Single-Use Introducer | 02/21/2020 |
| K240167 | Hunan Vathin Medical Instrument Co., Ltd. | Single-use Ureteral Access Sheath | 10/08/2024 |
| K251599 | Hunan Vathin Medical Instrument Co., Ltd. | Single-use Ureteral Access Sheath | 07/03/2025 |
| K200419 | Kalera Medical, Inc. | Kalera Vacuum Aspiration Catheter (K-VAC) | 05/22/2020 |
| K022686 | LAP SURGICAL SYSTEMS, LLC | LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE | 11/25/2002 |
| K250452 | MacroLux Medical Technology Co., Ltd. | CoralWellÖ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, | 06/02/2025 |
| K160846 | MEDIVATORS, INC. | AmplifEYE | 07/14/2016 |
| K190030 | Micro-Tech (Nanjing) Co., Ltd. | Embrella Endoscopic Distal Attachment | 03/05/2019 |
| K211301 | Neptune Medical, Inc. | Pathfinder Endoscope Overtube | 05/28/2021 |
| K191415 | Neptune Medical, Inc. | Pathfinder Endoscope Overtube | 08/30/2019 |
| K230801 | Neptune Medical, Inc. | Pathfinder Endoscope Overtube with Balloon Device | 07/28/2023 |
| K240853 | Neptune Medical, Inc. | Pathfinder« CR System | 06/27/2024 |
| K123013 | NOVADAQ TECHNOLOGIES, INC. | ENDOSCOPIC INTRODUCER | 03/22/2013 |
| K972781 | PRISM THERAPEUTICS, LLC. | OT-1 | 09/19/1997 |
| K061324 | RTC INC.-MEMCATH TECHNOLOGIES LLC | EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 | 06/20/2006 |
| K243025 | SEPLOU (ZHUHAI) CO., LTD. | Ureteral Access Sheath | 01/30/2025 |
| K250695 | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Single-use Ureteral Access Sheath | 07/08/2025 |
| K243710 | Shenzhen Trious Medical Technology Co., Ltd | Disposable ureteral access sheath | 04/11/2025 |
| K092156 | SOFTSCOPE MEDICAL TECHNOLOGIES, INC. | CAD 12, COLONOSCOPY ASSIST DEVICE | 10/14/2009 |
| K052084 | SPIRUS MEDICAL, INC. | ENDO-EASE ENDOSCOPIC OVERTUBE | 09/14/2005 |
| K062805 | SPIRUS MEDICAL, INC. | MODIFICATION TO ENDO-EASE | 10/13/2006 |
| K080050 | SPIRUS MEDICAL, INC. | SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE | 05/06/2008 |
| K182520 | Sumitomo Bakelite Co., Ltd | Flexible Overtube | 05/15/2019 |
| K002018 | SURGICAL, INC. | NDO SURGICAL SURGICAL OVERTUBE | 08/17/2000 |
| K203165 | Suzhou Beyo Medical Technology Co., Ltd. | Disposable Ureteral Access Sheath | 04/30/2021 |
| K200770 | Trokamed GmbH | Mini PCNL-System | 07/30/2021 |
| K131598 | UNITED STATES ENDOSCOPY GROUP, INC. | ANAL RECTAL OVERTUBE | 02/26/2014 |
| K092221 | UNITED STATES ENDOSCOPY GROUP, INC. | COLONIC SPLINTING OVERTUBE, MODEL 00711145 | 10/20/2009 |
| K040836 | UNITED STATES ENDOSCOPY GROUP, INC. | DISPOSABLE OVERTUBE | 06/10/2004 |
| K100081 | UNITED STATES ENDOSCOPY GROUP, INC. | ENTEROSCOPY OVERTUBE, MODEL 00712140 | 04/12/2010 |
| K051919 | USGI MEDICAL | MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE | 07/26/2005 |
| K050253 | USGI MEDICAL | USGI SHAPELOCK ENDOSCOPIC GUIDE | 02/28/2005 |
| K072405 | USGI MEDICAL | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE | 09/13/2007 |
| K061216 | USGI MEDICAL | USGI TRANSPORT ENDOSCOPIC GUIDE | 05/15/2006 |
| K033954 | USGI MEDICAL, INC. | SHAPE LOCKING ENDOSCOPIC OVERTUBE | 03/19/2004 |
| K023902 | USGI MEDICAL, INC. | SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE | 08/20/2003 |
| K171208 | Visionsense Ltd. | Trans-anal Introducer | 02/05/2018 |
| K151084 | WELL LEAD MEDICAL CO. LTD | Well Lead Ureteral Access Sheath | 01/07/2016 |
| K203119 | Well Lead Medical Co., LTD. | ClearPetra Suction-Evacuation Sheath | 12/09/2020 |
| K161110 | WELL LEAD MEDICAL CO., LTD. | ClearPetra Suction-Evacuation Sheath | 10/12/2016 |
| K230748 | YouCare Technology Co., Ltd. (Wuhan) | Disposable Ureteral Access Sheath | 08/02/2023 |
| K220065 | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Single Use Ureteral Access Sheath | 05/25/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
