FDA 510(k) Applications for Medical Device:
Endoscopic Injection Needle, Gastroenterology-Urology
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K002323 | ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K982890 | ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K002573 | ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K230925 | Alton (Shanghai) Medical Instruments Co. Ltd |
No.24 Building Jinshao Rd. 1688.Baoshan District. | Shanghai | 200949 | |
| K210917 | Anrei Medical (Hangzhou) Co., Ltd. |
No.3 Ave.8, HEDA | Hangzhou | 310018 | |
| K213239 | Beijing ZKSK Technology Co.,Ltd |
Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle | Beijing | 101105 | |
| K042882 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K961846 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K171454 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K092090 | BYRNE MEDICAL INC. |
3150 POLLOK DR | CONROE | TX | 77303 |
| K050688 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K133148 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K042615 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K030451 | CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K172227 | Carbon Medical Technologies, Inc. |
1290 Hammond Road | Saint Paul | MN | 55110-5867 |
| K090217 | COLOPLAST A/S |
1601 WEST RIVER ROAD N | MINNEAPOLIS | MN | 55411 |
| K171602 | Cook Incorporated |
750 Daniels Way, P.O. Box 489 | Bloomington | IN | 47402 |
| K113634 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | EL | |
| K022484 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K082319 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K012977 | ENDO-THERAPEUTICS, INC. |
1183 CEDAR ST. | SAFETY HARBOR | FL | 34695-2908 |
| K151475 | ENDOCHOICE, INC. |
11810 WILLS RD. | ALPHARETTA | GA | 30009 |
| K132065 | ENDOCHOICE, INC. |
11810 WILLS ROAD | ALPHARETTA | GA | 30009 |
| K000646 | ENTERIC MEDICAL TECHNOLOGIES |
1125 EAST HILLSDALE BLVD. | FOSTER CITY | CA | 94404 |
| K013712 | ENTERIC MEDICAL TECHNOLOGIES |
551 FOSTER CITY BLVD. | FOSTER CITY | CA | 94404 |
| K002778 | ENTERIC MEDICAL TECHNOLOGIES, INC. |
1125 EAST HILLSDALE BLVD. | FOSTER CITY | CA | 94404-1600 |
| K181690 | Finemedix Co. Ltd. |
60, Maeyeo-ro, Dong-gu | Daegu | 41065 | |
| K222006 | G-Flex Europe SPRL |
20, Rue de lÆindustrie | Nivelles | 1400 | |
| K001146 | GENY MEDICAL, INC. |
66 ARGONAUT # 170 | ALISO VIEJO | CA | 92656 |
| K990996 | GENYX MEDICAL, INC. |
36 ARGONAUT, SUITE 100 | ALISO VIEJO | CA | 92656-1467 |
| K190032 | Hangzhou AGS MedTech CO., Ltd |
Building 5, Building 6, Kangxin Road No.597 | Hangzhou | 310000 | |
| K010448 | HORIZONS INTL. CORP. |
287 MONTERREY ST. | PONCE | PR | 00732 |
| K221054 | Incore Co., Ltd. |
11, Hyeoksin-daero, 78-gil, Dong-gu | Daegu | 41072 | |
| K213914 | Jiangsu Vedkang Medical Science and Technology Co.,Ltd |
No. 52, Guoxiang Road, Wujin Economic Development Zone | Changzhou | 213149 | |
| K241523 | Laborie Medical Technologies Corp. |
180 International Drive | Portsmouth | NH | 03801 |
| K090830 | LABORIE MEDICAL TECHNOLOGIES, LTD. |
400 AVENUE D | WILLISTON | VT | 05495 |
| K221085 | LiNA Medical ApS |
Formervangen 5 | Glostrup | 2600 | |
| K960519 | MARTECH MEDICAL PRODUCTS, INC. |
1500 DELP DR. | HARLEYSVILLE | PA | 19438 |
| K955558 | MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 | TEMPE | AZ | 85283 |
| K061222 | MEDI-GLOBE CORP. |
110 WEST ORION, SUITE 136 | TEMPE | AZ | 85283 |
| K150434 | Micro-Tech (Nanjing) CO., Ltd. |
NO. 10 Gaoke Third Road | Nanjing | 210032 | |
| K232200 | Ningbo Xinwell Medical Technology Co., Ltd |
No.188 Binjiang Road, Cixi High-tech | Cixi | 315301 | |
| K192498 | Olympus Medical Systems Corp. |
2951 Ishikawa-machi | Hachioji-shi | 192-8507 | |
| K153625 | OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ISHIKAWA-CHO | HACHIOJI-SHI | 192-8507 | |
| K011484 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K043383 | PHYSION, INC. |
51 JOHN F. KENNEDY PKWY. | SHORT HILLS | NJ | 07078-5006 |
| K240675 | Promisemed Hangzhou Meditech Co., Ltd. |
No. 1388 Cangxing Street | Hangzhou City | 311121 | |
| K031238 | SCANDIMED. A.S. |
280 GODSHALL RD | COLLEGEVILLE | PA | 19426 |
| K232826 | STERIS |
5976 Heisley Rd | Mentor | OH | 44060 |
| K152035 | United States Endoscopy Group, Inc |
5976 Heisley Road | Mentor | OH | 44060 |
| K180214 | URO-1, Inc. |
391 Technology Way Suite 168 | Winston Salem | NC | 27101 |
| K051905 | UROPLASTY, INC. |
2718 SUMMER ST. NE | MINNEAPOLIS | MN | 55413-2820 |
| K091391 | UROPLASTY, INC. |
5420 FELTL RD. | MINNETONKA | MN | 55343 |
| K121337 | UROPLASTY, INC. |
5420 FELTL RD. | MINNETONKA | MN | 55343 |
| K241595 | Veol Medical Technologies Pvt Ltd. |
A 747, MIDC Pawane, TTC Industrial Area, Kopar Khairane, | Navi Mumbai | 400705 | |
| K142144 | WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
BLDG 5, NO. 258 SHUANGBANG ROAD | SHANG HAI | 201702 | |
| K111495 | WILSON-COOK MEDICAL INC. |
4900 Bethania Station Rd | WINSTON-SALEM | NC | 27105 |
| K190829 | Wilson-Cook Medical, Inc. / Cook Endoscopy |
4900 Bethania Station Road | Winston-Salem | NC | 27105 |
| K983765 | XIMED/PROSURE/INJECTX |
2195 TRADE ZONE BLVD. | SAN JOSE | CA | 95131 |
| K220292 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Beizhou Road, Lidian Town, Guangling District | Yangzhou | 225106 | |
| K212668 | Zhejiang Chuangxiang Medical Technology Co., LTD. |
| Hangzhou | 311100 | |
| K232442 | Zhejiang Soudon Medical Technology Co.,Ltd |
Room 302-1, Floor 3, Building 4, No.1 Nangonghe Road, | Hangzhou | 311100 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
