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 |
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 |
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 |
|
|
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 |
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 |
|
|