FDA 510(k) Applications for Medical Device:
Colonoscope And Accessories, Flexible/Rigid
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K043487 | AIZU OLYMPUS CO., LTD. |
TWO CORPORATE CENTER DRIVE | MELVILLE | NY | 11747-9058 |
| K230332 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K093187 | AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. | SUNNYVALE | CA | 94085 |
| K140595 | AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. | SUNNYVALE | CA | 94085 |
| K160356 | AVANTIS MEDICAL SYSTEMS, INC. |
2367 BERING DRIVE | San Jose | CA | 95131 |
| K091783 | AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. | SUNNYVALE | CA | 94085 |
| K070330 | AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. | SUNNYVALE | CA | 94085 |
| K083180 | AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. | SUNNYVALE | CA | 94085 |
| K213773 | Bpendo, LLC |
216 Foreman Circle | Norman | OK | 73069 |
| K091305 | EASYGLIDE LTD. |
24301 WOODSAGE DR. | BONITA SPRINGS | FL | 34134 |
| K113050 | EASYGLIDE LTD. |
24301 WOODSAGE DR. | BONITA SPRINGS | FL | 34134 |
| K132839 | ENDOCHOICE, INC. |
11810 WILLS ROAD | ALPHARETTA | GA | 30009 |
| K141598 | ENDOCHOICE, INC. |
3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) | CAESAREA | 3088900 | |
| K190669 | Era Endoscopy s.r.l. |
Via Boccioni, 1 | Peccioli | 56037 | |
| K223827 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K190649 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K192664 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K180405 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K153483 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
10 HIGH POINT DR | WAYNE | NJ | 07470 |
| K132210 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
10 HIGH POINT DR | WAYNE | NJ | 07470 |
| K143732 | FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K162622 | FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K160196 | FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive | Wayne | NJ | 07470 |
| K090116 | FUJINON, INC. |
1-324 UETAKE-CHO | KITA- KU SAITAMA | 331-9624 | |
| K112391 | FUJINON, INC. |
10 HIGH POINT DR. | WAYNE | NJ | 07470 |
| K041903 | FUJINON, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K171673 | GCE Medical Corporation |
2723 West Tenaya | Fresno | CA | 93711 |
| K161791 | GI View Ltd. |
5 Shoham St. | Ramat Gan | 5251001 | |
| K230588 | GI View Ltd. |
5 Shoham St. | Ramat Gan | 5251001 | |
| K141286 | GI VIEW LTD. |
901 NEW YORK AVENUE, N.W | WASHINGTON D.C | DC | 20001 |
| K213578 | Hangzhou AGS MedTech Co., Ltd. |
Building 5, Building 6, No.597 Kangxin Road Yuhang District | Hangzhou | 311106 | |
| K023259 | HELIX MEDICAL, INC. |
1110 MARK AVE. | CARPINTERIA | CA | 93013 |
| K100624 | INVENDO MEDICAL GBMH |
PETERHOFSTRAUSSE 3B | KISSING | 86438 | |
| K121582 | INVENDO MEDICAL GBMH |
PETERHOFSTR. 3B | KISSING | 86438 | |
| K161355 | Invendo Medical GmbH |
Peterhofstr. 3b | Kissing | 86438 | |
| K173085 | invendo medical GmbH |
Peterhofstr. 3 b | Kissing | 86438 | |
| K063585 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K063654 | KMS MEDICAL LLC |
7290 SW 42ND STREET | MIAMI | FL | 33155 |
| K221452 | Lumendi, LLC |
253 Post Road West | Westport | CT | 06880 |
| K211819 | Lumendi, LLC |
253 Post Road West | Westport | CT | 06880 |
| K173317 | Lumendi, LLC |
253 Post Road West | Westport | CT | 06880 |
| K162428 | Lumendi, LLC |
253 Post Road West | Westport | CT | 06880 |
| K182540 | Lumendi, LLC |
253 Post Road West | Westport | CT | 06880 |
| K210851 | Lumendi, LLC |
253 Post Road West | Westport | CT | 06880 |
| K162330 | Medrobotics Corporation |
475 Paramount Drive | Raynham | MD | 02767 |
| K172036 | Medrobotics Corporation |
475 Paramount Drive | Raynham | MA | 02767 |
| K160015 | Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. | Tirat Carmel | 3902638 | |
| K181437 | Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. | Tirat Carmel | 3902638 | |
| K191220 | Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. | Tirat Carmel | 3902638 | |
| K210981 | Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod Str. | Tirat Carmel | 3902638 | |
| K220007 | Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod Str. | Tirat Carmel | 3902638 | |
| K173392 | Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. | Tirat Carmel | 3902638 | |
| K052930 | NEOGUIDE SYSTEMS, INC. |
104 COOPER COURT | LOS GATOS | CA | 95032 |
| K070622 | NEOGUIDE SYSTEMS, INC. |
104 COOPER COURT | LOS GATOS | CA | 95032 |
| K051541 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K192793 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K131780 | OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K111756 | OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K112680 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K101053 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
REGULATORY AFFAIRS & QUALITY | CENTER VALLEY | PA | 18034-0610 |
| K103312 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K120289 | PEERMEDICAL |
6 SIRENI | HAIFA | 32972 | |
| K130718 | PEERMEDICAL LTD. |
2 HATOCHEN ST | CAESAREA | 38900 | |
| K131855 | PENTAX MEDICAL COMPANY |
3 PARAGON DRIVE | MONTVALE | NJ | 07645 |
| K093037 | PENTAX MEDICAL COMPANY |
102 CHESTNUT RIDGE RD. | MONTVALE | NJ | 07645-1856 |
| K180285 | PENTAX Medical of America, Inc |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K181084 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K951574 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K951579 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K961563 | PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. | ORANGEBURG | NY | 10962 |
| K961570 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K970372 | PRECISION ENDOSCOPY OF AMERICA, INC. |
10969 MCCORMICK RD. | HUNT VALLEY | MD | 21031 |
| K210052 | Saneso Inc. |
One Oxford Center, 301 Grant Street Suite 4300 | Pittsburgh | PA | 15219 |
| K100966 | SHEATHING TECHNOLOGIES, INC. |
18431 TECHNOLOGY DR. | MORGAN HILL | CA | 95037 |
| K032688 | SIGHTLINE TECHNOLOGIES LTD. |
MATAM - BLDG. 20 | HAIFA | 31905 | |
| K220158 | Smart Medical Systems Ltd. |
5 HaNofar St. | Ra'anana | 4366404 | |
| K192588 | SMART Medical Systems Ltd. |
5 HaNofar St. | Raanana | 4366404 | |
| K202469 | SMART Medical Systems Ltd. |
5 HaNofar Street | Raanana | 4366404 | |
| K102616 | SMART MEDICAL SYSTEMS, LTD. |
10 HAYETSIRA STREET | RAANANA | 43663 | |
| K101191 | SMART MEDICAL SYSTEMS, LTD. |
10 HAYETSIRA STREET | RAANANA | 43663 | |
| K081004 | STRYKER GI |
1420 LAKESIDE PARKWAY, #110 | FLOWER MOUND | TX | 75028 |
| K080317 | SYNTHEON LLC |
7290 SW 42ND ST. | MIAMI | FL | 33155 |
| K002749 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K001241 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K111028 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K163492 | United states Endoscopy Group, Inc. |
5976 Heisley Road | Mentor | OH | 44060 |
| K954704 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K051068 | ZUTRON MEDICAL |
9816 PFLUMM RD | LENEXA | KS | 66215 |
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