FDA 510(k) Applications for Medical Device:
Forceps, Biopsy, Electric
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090583 | APOLLO ENDOSURGERY, INC. |
7000 BEE CAVES RD. SUITE 350 | AUSTIN | TX | 78746 |
| K231721 | Beijing ZKSK Technology Co.,Ltd |
Building 9, 6 & No.6 Yuan Hengye North 7th Street, | Beijing | 101105 | |
| K101657 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K090796 | ENDO-THERAPEUTICS, INC. |
15251 ROOSEVELT BLVD. | CLEARWATER | FL | 33760 |
| K131991 | ENDOCHOICE, INC. |
11810 WILLS ROAD | ALPHARETTA | GA | 30009 |
| K242857 | Finemedix Co., Ltd. |
140-9, Yuram-ro, Dong-gu | Daegu | 41059 | |
| K220053 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K151474 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K171096 | FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K161186 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K210406 | Hangzhou AGS MedTech Co., Ltd. |
Building 5, Building 6, No. 597 Kangxin Road Yuhang District | Hangzhou | 311106 | |
| K021706 | HORIZONS INTL. CORP. |
287 MONTERREY ST. | PONCE | PR | 00717 |
| K022243 | HORIZONS INTL. CORP. |
287 MONTERREY ST. | PONCE | PR | 00717 |
| K971204 | LSVP INTL., INC. |
12755 ALTO VERDE LN. | LOS ALTOS HILLS | CA | 94022 |
| K953355 | MEDI-GLOBE CORP. |
6202 SOUTH MAPLE AVE. # 131 | TEMPE | AZ | 85283 |
| K022751 | MEDICAL DEVICE SERVICES |
144 WEST BRIGHAM RD. | ST. GEORGE | UT | 84790 |
| K160625 | MICRO-TECH (NANJING) CO., LTD. |
NO. 10 GAOKE THIRD ROAD | NANJING | 210032 | |
| K180018 | Micro-Tech (Nanjing) CO., Ltd. |
NO. 10 Gaoke Third Road | Nanjing | 210032 | |
| K202438 | Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Thrid Road | Nanjing | 210032 | |
| K955052 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K171916 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K062517 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K983811 | OLYMPUS WINTER & IBE GMBH |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K141794 | OVESCO ENDOSCOPY AG |
DORFACKERSTRASSE 26 | TUEBINGEN, BADEN-WUERTTEMBERG | 72074 | |
| K970083 | PORTLYN CORP. |
RFD #1 BOX 451, ROUTE 25 | MOULTONBORO | NH | 03254 |
| K180134 | Slater Endoscopy, LLC |
14000 NW 58 Court | Miami Lakes | FL | 33014 |
| K183428 | STERIS Corporation |
5976 Heisley Rd | Mentor | OH | 44060 |
| K992390 | TELEMED SYSTEMS, INC. |
19 BRIGHAM ST., UNIT 1 | MARLBOROUGH | MA | 01752 |
| K972505 | UNITED STATES ENDOSCOPY GROUP, INC. |
9330 PROGRESS PKWY. | MENTOR | OH | 44060 |
| K171973 | Wilson-Cook Medical, Inc. |
4900 Bethania Station Road | Winston-Salem | NC | 27105 |
| K000086 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & | WINSTON-SALEM | NC | 27105 |
| K990231 | WILTEK MEDICAL, INC. |
101 NORTH CHESTNUT ST., #300 | WINSTON-SALEM | NC | 27101 |
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