FDA 510(k) Applications for Medical Device:
Endoscopic Access Overtube, Gastroenterology-Urology
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K082102 | APOLLO ENDOSURGERY, INC. |
7000 BEE CAVES RD. SUITE 350 | AUSTIN | TX | 78746 |
| K122270 | APOLLO ENDOSURGERY, INC. |
7000 BEE CAVES RD. SUITE 350 | AUSTIN | TX | 78746 |
| K990775 | APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE | LAGUNA HILLS | CA | 92653 |
| K993650 | APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE | LAGUNA HILLS | CA | 92653 |
| K030642 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K172575 | BAROnova, Inc. |
1509 Industrial Road | San Carlos | CA | 94070 |
| K082589 | BAROSENSE, INC |
3698-C HAVEN AVENUE | REDWOOD CITY | CA | 94063 |
| K120126 | BAROSENSE, INC |
250 CHESAPEAKE DRIVE | REDWOOD CITY | CA | 94063 |
| K122565 | BODDINGTONS PLASTICS LTD |
UNIT 6 WHEELBARROW PARK ESTATE | TONBRIDGE, KENT | TN12 9QL | |
| K162205 | BODDINGTONS PLASTICS LTD |
UNIT 6 PATTENDEN LANE, | TONBRIDGE | TN12 9QJ | |
| K191067 | Boddingtons Plastics Ltd |
Wheelbarrow Park Estate, Pattenden Lane, Marden | Tonbridge | Tn12 9QJ | |
| K151801 | BODDINGTONS PLASTICS LTD |
WHEELBARROW PARK ESTATE | TONBRIDGE | TN12 9QL | |
| K140323 | BOSTON SCIENTIFIC |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K173400 | Boston Scientific |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K122649 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K030956 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K051504 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K250517 | Boston Scientific Corporation |
100 Boston Scientific Way û Urology Division | Marlborough | MA | 01752 |
| K030438 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K973500 | C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 | BILLERICA | MA | 01821 |
| K033778 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD | COVINGTON | GA | 30014 |
| K160861 | C.R. Bard, Inc. |
8195 Industrial Blvd | Covington | GA | 30014 |
| K150083 | C2 THERAPEUTICS |
303 CONVENTION WAY | REDWOOD CITY | CA | 94063 |
| K233472 | Calyxo, Inc. |
4473 Willow Road | Pleasanton | CA | 94588 |
| K250585 | CatheGenix (Xiamen) Co., Ltd. |
Room 605-2A, No.37 Banshang, Building 2, | Xiamen | 361000 | |
| K102485 | COLOPLAST A/S |
1601 WEST RIVER ROAD N | MINNEAPOLIS | MN | 55411 |
| K123675 | COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH | MINNEAPOLIS | MN | 55411 |
| K140523 | COLOPLAST A/S |
1601 WEST RIVER ROAD N | MINNEAPOLIS | MN | 55411 |
| K181811 | Coloplast A/S |
1601 West River Road North | Minneapolis | MN | 55411 |
| K242173 | Coloplast Corp. |
1601 West River Road North | Minneapolis | MN | 55411 |
| K983415 | CONWAY STUART MEDICAL, INC. |
735 PALOMAR ST. | SUNNYVALE | CA | 94086 |
| K172217 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K182403 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K043418 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K110531 | CROSPON, LTD. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K241181 | Dongguan ZSR Biomedical technology Company Limited |
Unit 448, Qingfeng Road, Taihu Village, Sanzhong Village | Dongguan | 523651 | |
| K243820 | Dornier MedTech America |
1155 Roberts Blvd | Kennesaw | GA | 30144 |
| K201815 | Dornier MedTech America Inc |
1155 Roberts Blvd, Suite 100 | Kennesaw | GA | 30144 |
| K133359 | ENDO-AID, INC. |
1835 MARKET STREET, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K243091 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K230752 | Fujifilm Healthcare Americas Corporation |
81 Hartwell Avenue | Lexington | MA | 02421 |
| K091773 | FUJINON, INC. |
80 SHELTON TECHNOLOGY CENTER | SHELTON | CT | 06484 |
| K192691 | H&A Mui Enterprises Inc. |
145 Traders Blvd. E., Unit #34 | Mississauga | L4Z 3L3 | |
| K240167 | Hunan Vathin Medical Instrument Co., Ltd. |
1/F, Building 12, Innovation Entrepreneurship Service Center | Xiangtan | 411100 | |
| K251599 | Hunan Vathin Medical Instrument Co., Ltd. |
1/F, Building 12, Innovation Entrepreneurship Service Center | Xiangtan | 411100 | |
| K200419 | Kalera Medical, Inc. |
13240 Evening Creek Drive S., Suite 304 | San Diego | CA | 92128 |
| K022686 | LAP SURGICAL SYSTEMS, LLC |
100 NORTH PENNSYLVANIA | ROSWELL | NM | 88203 |
| K250452 | MacroLux Medical Technology Co., Ltd. |
301, Building 3, NamTai Inno Park In Guang Ming Avenue | Shenzhen | 518107 | |
| K160846 | MEDIVATORS, INC. |
3150 POLLOK DR. | CONROE | TX | 77303 |
| K190030 | Micro-Tech (Nanjing) Co., Ltd. |
NO. 10 Gaoke Third Road | Nanjing | 210032 | |
| K211301 | Neptune Medical, Inc. |
1828 El Camino Real | Burlingame | CA | 94010 |
| K191415 | Neptune Medical, Inc. |
1828 El Camino Real, Suite 508 | Burlingame | CA | 94010 |
| K230801 | Neptune Medical, Inc. |
1828 El Camino Real, Suite 508 | Burlingame | CA | 94010 |
| K240853 | Neptune Medical, Inc. |
1828 El Camino Real, Suite 508 | Burlingame | CA | 94010 |
| K123013 | NOVADAQ TECHNOLOGIES, INC. |
13155 DELF PLACE, UNIT 250 | RICHMOND, BRITISH COLUMBIA | V6V 2A2 | |
| K972781 | PRISM THERAPEUTICS, LLC. |
11504 RIVEREDGE RD. | DOSWELL | VA | 23047 |
| K061324 | RTC INC.-MEMCATH TECHNOLOGIES LLC |
1777 OAKDALE AVE., | WEST ST. PAUL | MN | 55118 |
| K243025 | SEPLOU (ZHUHAI) CO., LTD. |
5th Floor, Building 1, No. 8, Keji 10th Road | Zhuhai | 519086 | |
| K250695 | Shenzhen HugeMed Medical Technical Development Co., Ltd. |
401, 501, Building 4, Haizhi Technology Park, Fortis | Shenzhen | 518112 | |
| K243710 | Shenzhen Trious Medical Technology Co., Ltd |
Rm 102-2, Longtian Tongfuyu Ind Estate #11-3 & Rm 401 & 402 | Shenzhen | ||
| K092156 | SOFTSCOPE MEDICAL TECHNOLOGIES, INC. |
4486 TIMBERLINE CT. | VADNAIS HEIGHTS | MN | 55127 |
| K052084 | SPIRUS MEDICAL, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K062805 | SPIRUS MEDICAL, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K080050 | SPIRUS MEDICAL, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K182520 | Sumitomo Bakelite Co., Ltd |
5-8, Higashi-Shinagawa 2-chome | Shinagawa-ku | 1400002 | |
| K002018 | SURGICAL, INC. |
125 HIGH STREET, SUITE 7 | MANSFIELD | MA | 02048 |
| K203165 | Suzhou Beyo Medical Technology Co., Ltd. |
No. 38 Beiguandu Road | Suzhou | 215000 | |
| K200770 | Trokamed GmbH |
Kleine Breite 17 | Geisingen | 78187 | |
| K131598 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K092221 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K040836 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K100081 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K051919 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K050253 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K072405 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K061216 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K033954 | USGI MEDICAL, INC. |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K023902 | USGI MEDICAL, INC. |
2 DELPHINUS | IRVINE | CA | 92612 |
| K171208 | Visionsense Ltd. |
20 Hamagshimim St. | Petach Tikva, Hamerkaz | 49348 | |
| K151084 | WELL LEAD MEDICAL CO. LTD |
C-4 JINHU INDUSTRIAL ESTATE | GUANGZHOU | 511434 | |
| K203119 | Well Lead Medical Co., LTD. |
C-4# Jinhu Industrial Estate, Hualong, Panyu | Guangzhou | 511434 | |
| K161110 | WELL LEAD MEDICAL CO., LTD. |
C-4#Jinhu Industrial Estate, Hualong, Panyu | Guangzhou | 511434 | |
| K230748 | YouCare Technology Co., Ltd. (Wuhan) |
Tangxunhu North Street | Wuhan | 430000 | |
| K220065 | Zhejiang Chuangxiang Medical Technology Co., Ltd. |
Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road | Hangzhou | 311100 |
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