FDA 510(k) Applications for Medical Device:
Gastroscope And Accessories, Flexible/Rigid
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K242635 | Alton (Shanghai) Medical Instruments Co. Ltd |
No.24 Building Jinshao Rd.1688.Baoshan District | Shanghai | 200949 | |
| K232919 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K212382 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K093779 | EASYGLIDE LTD. |
24301 WOODSAGE DR. | BONITA SPRINGS | FL | 34134 |
| K113166 | EASYGLIDE LTD. |
24301 WOODSAGE DR. | BONITA SPRINGS | FL | 34134 |
| K152182 | ENDOCHOICE INC. |
11810 WILLS RD. | ALPHARETTA | GA | 30009 |
| K131422 | ENDOCHOICE, INC. |
2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) | CAESAREA | 38900 | |
| K213606 | EvoEndo Inc |
12649 East Caley Ave, Suite 116 | Centennial | CO | 80111 |
| K250900 | EvoEndo, Inc. |
888 East Belvidere Road | Grayslake | IL | 60030 |
| K974493 | FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH |
GAENSAECKER 42 | TUTTLINGEN | D-78532 | |
| K212296 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K210162 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K180341 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K193123 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K183686 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K182836 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K240142 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K243512 | FUJIFILM Corporation |
798 Miyanodai Kaisei-MachiI | Ashigara Kami-Gun | 258-8538 | |
| K183572 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K172916 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun Kanagawa | 258-8538 | |
| K181763 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K200850 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K242779 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K221551 | FUJIFILM Corporaton |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K232314 | Fujifilm Healthcare Americas Corporation |
81 Hartwell Avenue | Lexington | MA | 02421 |
| K142629 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K153206 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K162749 | FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K111243 | FUJINON INC. |
419 WEST AVENUE | STAMFORD | CT | 06902 |
| K042043 | FUJINON, INC. |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K063316 | FUJINON, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K063847 | FUJINON, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K120446 | FUJINON, INC. |
10 HIGH POINT DR. | WAYNE | NJ | 07470 |
| K140295 | GI SCIENTIFIC LLC |
128 Blye HIll Landing | Newbury | NH | 03255 |
| K192704 | HuiZhou Xzing Technology Co., Ltd. |
4th Floor, Building D, S-16-2 Southern park | Huizhou | 516000 | |
| K232028 | IQ Endoscopes Limited |
Basepoint Business Centre, Riverside Court Beaufort Park Way | Chepstow | NP16 5UH | |
| K060907 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE DRIVE | CULVER CITY | CA | 90230 |
| K243388 | Micro-Tech (Nanjing) Co., Ltd. |
No.10 Gaoke Third Rd | Nanjing | 210032 | |
| K210915 | Neptune Medical, Inc. |
1828 El Camino Real, Suite 508 | Burlingame | CA | 94010 |
| K984358 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K971660 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K963023 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K250296 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachiochi-shi | 192-8507 | |
| K232997 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho | Tokyo | ||
| K123317 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K002231 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K021886 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K001766 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K032177 | OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K131902 | PENTAX MEDICAL COMPANY |
3 PARAGON DRIVE | MONTVALE | NJ | 07645 |
| K180292 | PENTAX Medical of America, Inc |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K241213 | Pentax of America, Inc |
3 Paragon Dr | Montvale | NJ | 07645 |
| K190799 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K210485 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K210177 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K961564 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K962897 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K013640 | PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. | ORANGEBURG | NY | 10962 |
| K962460 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K173004 | Sumitomo Bakelite Co., Ltd |
5-8, Higashi-Shinagawa 2-chome | Shinagawa-ku | 1400002 | |
| K011151 | THE OLYMPUS OPTICAL CO. |
ENDOSCOPE DIVISION | MELVILLE | NY | 11747-3157 |
| K130148 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 Heisley Rd | Mentor | OH | 44060 |
| K180911 | Visura Technologies, LLC |
9337 Harding Avenue | Evanston | IL | 60203 |
| K971734 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
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