FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K002323 |
ADVANCED UROSCIENCE, INC. |
ADVANCED UROSCIENCE INJECTION NEEDLE |
07/31/2000 |
K982890 |
ADVANCED UROSCIENCE, INC. |
ADVANCED UROSCIENCE INJECTION NEEDLE |
10/26/1998 |
K002573 |
ADVANCED UROSCIENCE, INC. |
ADVANCED UROSCIENCE INNERSHEATH |
11/16/2000 |
K230925 |
Alton (Shanghai) Medical Instruments Co. Ltd |
Disposable Injection Needle AF series |
09/27/2023 |
K210917 |
Anrei Medical (Hangzhou) Co., Ltd. |
Single Use Injection Needle |
05/28/2021 |
K213239 |
Beijing ZKSK Technology Co.,Ltd |
Endoscopic Injection Needle |
06/02/2022 |
K042882 |
BOSTON SCIENTIFIC CORP. |
ENTERYX INJECTION CATHETER |
11/09/2004 |
K961846 |
BOSTON SCIENTIFIC CORP. |
NEEDLE CATHETER |
07/15/1996 |
K171454 |
Boston Scientific Corporation |
Interject Injection Therapy Needle Catheter |
07/07/2017 |
K092090 |
BYRNE MEDICAL INC. |
ERBELIFT HAND PUMP AND FLEXIBLE PROBE |
11/30/2009 |
K050688 |
C.R. BARD, INC. |
TEGRESS IMPLANT NEEDLE |
04/06/2005 |
K133148 |
CARBON MEDICAL TECHNOLOGIES, INC. |
BIOMARC COAXIAL NEEDLE |
05/13/2014 |
K042615 |
CARBON MEDICAL TECHNOLOGIES, INC. |
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE |
11/05/2004 |
K030451 |
CARBON MEDICAL TECHNOLOGIES, INC. |
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE |
04/30/2003 |
K172227 |
Carbon Medical Technologies, Inc. |
Endoscopic Injection Needle |
08/23/2017 |
K090217 |
COLOPLAST A/S |
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 |
04/23/2009 |
K171602 |
Cook Incorporated |
Williams Cystoscopic Injection Needle |
07/28/2017 |
K113634 |
COOK IRELAND LTD |
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE |
02/14/2012 |
K022484 |
COOK UROLOGICAL, INC. |
COOK INJECTION NEEDLE |
10/25/2002 |
K082319 |
COOK UROLOGICAL, INC. |
INJEKT FILIFORM INJECTION NEEDLE |
09/25/2008 |
K012977 |
ENDO-THERAPEUTICS, INC. |
VARICES INJECTION NEEDLE |
11/02/2001 |
K151475 |
ENDOCHOICE, INC. |
EndoChoice Select Injection Needle |
02/08/2016 |
K132065 |
ENDOCHOICE, INC. |
INJECTION NEEDLE |
01/17/2014 |
K000646 |
ENTERIC MEDICAL TECHNOLOGIES |
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE |
04/13/2000 |
K013712 |
ENTERIC MEDICAL TECHNOLOGIES |
ENTERYX INJECTOR |
05/31/2002 |
K002778 |
ENTERIC MEDICAL TECHNOLOGIES, INC. |
ENTERIC INJECTION CATHETER WITH IRRIGATION |
11/22/2000 |
K181690 |
Finemedix Co. Ltd. |
Clear-Jet Injection Catheter |
12/21/2018 |
K222006 |
G-Flex Europe SPRL |
Sclerotherapy & Endoscopic Needles |
04/03/2023 |
K001146 |
GENY MEDICAL, INC. |
GENYX FLEXIBLE INJECTION NEEEDLE |
06/30/2000 |
K990996 |
GENYX MEDICAL, INC. |
GENYX MEDICAL INJECTION NEEDLE |
06/18/1999 |
K190032 |
Hangzhou AGS MedTech CO., Ltd |
Disposable Sclerotherapy Needle |
02/27/2020 |
K010448 |
HORIZONS INTL. CORP. |
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES |
05/16/2001 |
K221054 |
Incore Co., Ltd. |
CORE-INJECTOR |
12/21/2022 |
K213914 |
Jiangsu Vedkang Medical Science and Technology Co.,Ltd |
Injection Needle |
07/29/2022 |
K090830 |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP |
07/21/2009 |
K221085 |
LiNA Medical ApS |
LiNA OperaScope Needle |
09/02/2022 |
K960519 |
MARTECH MEDICAL PRODUCTS, INC. |
MARTECH ENDOSCOPIC INJECTION NEEDLE |
05/01/1996 |
K955558 |
MEDI-GLOBE CORP. |
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES |
02/29/1996 |
K061222 |
MEDI-GLOBE CORP. |
INJECTRA INJECTION NEEDLE |
07/03/2006 |
K150434 |
Micro-Tech (Nanjing) CO., Ltd. |
Injection Needle |
06/02/2015 |
K192498 |
Olympus Medical Systems Corp. |
Single Use Injector |
04/28/2020 |
K153625 |
OLYMPUS MEDICAL SYSTEMS CORP. |
Single Use Injector NM600/610 |
02/12/2016 |
K011484 |
OLYMPUS OPTICAL CO., LTD. |
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 |
08/10/2001 |
K043383 |
PHYSION, INC. |
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 |
10/27/2005 |
K031238 |
SCANDIMED. A.S. |
VARICES NEEDLE |
10/04/2004 |
K152035 |
United States Endoscopy Group, Inc |
iSnare system-Lariat |
10/15/2015 |
K180214 |
URO-1, Inc. |
Repris Bladder Injection System |
05/03/2018 |
K051905 |
UROPLASTY, INC. |
UROPLASTY RIGID ENDOSCOPIC NEEDLE |
08/29/2005 |
K091391 |
UROPLASTY, INC. |
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 |
06/30/2009 |
K121337 |
UROPLASTY, INC. |
UROPLASTY RIGID ENDOSCPIC NEEDLES |
08/03/2012 |
K142144 |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
DISPOSABLE INJECTION NEEDLE |
01/15/2015 |
K111495 |
WILSON-COOK MEDICAL INC. |
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K |
07/19/2011 |
K190829 |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) |
12/19/2019 |
K983765 |
XIMED/PROSURE/INJECTX |
INJECTION NEEDLE PROBE/DEVICE-TUNIS |
12/11/1998 |
K220292 |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Disposable Endoscope Injection Needle |
08/19/2022 |
K212668 |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Sclerotherapy Needle |
02/23/2022 |