FDA 510(k) Applications for Medical Device:
Endoscopic Irrigation/Suction System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K222695 | Biotex Inc. |
114 Holmes Rd. | Houston | TX | 77045 |
| K233442 | Biotex, Inc. |
114 Holmes Rd. | Houston | TX | 77045 |
| K130909 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K182275 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K031773 | BYRNE MEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K113119 | BYRNE MEDICAL, INC. |
14605 28TH AVENUE NORTH | MINNEAPOLIS | MN | 55442 |
| K060962 | BYRNE MEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K033695 | BYRNE MEDICAL, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K102855 | BYRNE MEDICAL, INC. |
3150 POLLOCK DR. | CONROE | TX | 77303 |
| K152140 | C2 THERAPEUTICS, INC. |
303 CONVENTION WAY, SUITE 1 | REDWOOD CITY | CA | 94063 |
| K020614 | CA GUARD, LTD. |
19526 EAST LAKE DR. | MIAMI | FL | 33015 |
| K221310 | Changzhou Endoclean Medical Device Co., Ltd. |
West Side of 4th Floor, Building E2, No.9 Changyang Road | Changzhou | 213149 | |
| K210618 | Chongqing Jinshan Science & Technology Co., Ltd. |
Yubei District No.18 Ningshang Avenue | Chongqing | 400000 | |
| K221824 | Cipher Surgical Limited |
The Venture Centre, Sir William Lyons Road | Coventry | CV4 7EZ | |
| K171637 | Cipher Surgical Ltd |
The Venture Centre, Sir William Lyons Road | Coventry | CV4 7EZ | |
| K970764 | COMEG ENDOSCOPY |
13790 EAST RICE PLACE | AURORA | CO | 80015 |
| K222734 | Diversatek Healthcare |
102 E. Keefe Ave. | Milwaukee | WI | 53212 |
| K992535 | ENDIUS, INC. |
23 WEST BACON ST. | PLAINVILLE | MA | 02762 |
| K971125 | ENDO SMART CAP CO. |
16800 IMPERIAL VALLEY DR., | HOUSTON | TX | 77060 |
| K111821 | ENDOCHOICE, INC. |
11810 WILLS ROAD | ALPHARETTA | GA | 30009 |
| K132776 | ENDOCHOICE, INC. |
11810 WILLS ROAD | ALPHARETTA | GA | 30009 |
| K133734 | ENDOCHOICE, INC. |
11810 WILLS RD. | ALPHARETTA | GA | 30009 |
| K161167 | ENDOCHOICE, INC. |
11810 WILLS ROAD | ALPHARETTA | GA | 30009 |
| K143186 | ERBE USA, INC. |
2225 NORTHWEST PARKWAY | MARIETTA | GA | 30067 |
| K221177 | Erbe USA, Inc. |
2225 Northwest Parkway | Marietta | GA | 30067 |
| K190469 | Erbe USA, Inc. |
2225 Northwest Parkway | Marietta | GA | 30067 |
| K103235 | ERBE USA, INC. |
2225 NORTHWEST PKWY. | MARIETTA | GA | 30067 |
| K191438 | Erbe USA, Inc. |
2225 Northwest Parkway | Marietta | GA | 30067 |
| K182444 | Erbe USA, Inc. |
2225 Northwest Parkway | Marietta | GA | 30067 |
| K242134 | FINEMEDIX Co., Ltd. |
140-9, Yuram-Ro, Dong-Gu | Daegu | 41059 | |
| K202616 | Finemedix Co., Ltd. |
60, Maeyeo-ro, Dong-gu | Daegu | 41065 | |
| K230932 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K200479 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K202560 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K223171 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K231602 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K200388 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K241704 | Hangzhou AGS MedTech Co., Ltd. |
Building 5,Building 6, No.597 Kangxin Road Yuhang District | Hangzhou | 311106 | |
| K241874 | Hobbs Medical, Inc. |
8 Spring St | Stafford Springs | CT | 06076 |
| K030765 | HOBBS MEDICAL, INC. |
8 SPRING ST. | STAFFORD SPRINGS | CT | 06076 |
| K111274 | JETPREP, LTD. |
COLUMBIA SQUARE | WASHINGTON | DC | 20004 |
| K122740 | JETPREP, LTD. |
COLUMBIA SQUARE | WASHINGTON | DC | 20004 |
| K021776 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K031457 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K193250 | KeyMed (Medical and Industrial Equipment) Ltd. |
KeyMed House, Stock Road | Southend-on-Sea | SS2 5QH | |
| K140753 | MEDIVATORS |
14605 28TH AVE. N. | MINNEAPOLIS | MN | 55447 |
| K231418 | Medivators |
14605 28th Avenue North | Minneapolis | MN | 55447 |
| K131426 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K142068 | MEDOVATIONS, INC. |
102 EAST KEEFE AVE. | MILWAUKEE | WI | 53212 |
| K203350 | Nissha Medical Technologies SAS |
ZA Des Boutries 12 Rue Des Cayennes | Conflans STE Honorine | 78700 | |
| K964196 | NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. | ELGIN | IL | 60123 |
| K993778 | NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. | ELGIN | IL | 60123 |
| K242357 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K242586 | Ovesco Endoscopy AG |
Friedrich-Miescher-Strasse 9 | Tuebingen | 72076 | |
| K181457 | Partnership Medical Limited |
Hartley House, Galveston Grove | Fenton | ST43PE | |
| K181418 | Partnership Medical Limited |
Hartley House, Galveston Grove | Fenton | ST43PE | |
| K193036 | PENTAX Medical, A Division of PENTAX of America, Inc. |
303 Convention Way, Suite 1 | Redwood City | CA | 94063 |
| K112318 | PROMEDIC, INC. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K152278 | PROMEPLA SAM |
9 AVENUE ALBERT II | MONACO | 98000 | |
| K222173 | Saneso, Inc. |
One Oxford Center, 301 Grant Street Suite 4300 | Pittsburg | PA | 15219 |
| K182998 | Smartdata Suzhou Co., Ltd |
4f, Block 7, 198#, Jinshan Rd | Suzhou | 215011 | |
| K181509 | Smartdata Suzhou Co., Ltd |
4f, Block 7, 198#, Jinshan Rd | Suzhou | 215011 | |
| K191366 | Smartdata Suzhou Co., Ltd |
4f, Block 7, 198#, Jinshan Rd | Suzhou | 215011 | |
| K122417 | THE RUHOF CORP. |
611 WEST 5TH STREET | AUSTIN | TX | 78701 |
| K092461 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K103239 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K140405 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K140315 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K182319 | Wilson-Cook Medical, Inc. |
4900 Bethania Station Road | Winston-Salem | NC | 27105 |
| K220785 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Beizhou Road, Lidian Town, Guangling District | Yangzhou | 225106 | |
| K231471 | Zhejiang Chuangxiang Medical Technology Co., LTD. |
Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road | Hangzhou | 311100 | |
| K173758 | Zhejiang Chuangxiang Medical Technology Co., LTD. |
301B, No.22, XinYan Road | Hanzhou | 311100 | |
| K230773 | Zhejiang Chuangxiang Medical Technology Co., LTD. |
Room 101,201,301,401,501, Building 50, | Hangzhou | 311100 |
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