FDA 510(k) Applications for Medical Device:
Endoscopic Tissue Approximation Device
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K003949 |
A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE
| ALPHARETTA |
GA |
30004-3383 |
K962493 |
AESCULAP, INC. |
1000 GATEWAY BLVD.
| SOUTH SAN FRANCISCO |
CA |
94080 |
K201744 |
Anchora Medical, Ltd. |
Beit Tavor, Entrance 2, 3rd floor
| I.Z. Yokneam |
|
2069202 |
K191439 |
Apollo Endosurgery |
1120 S. Capital of Texas Hwy
| Austin |
TX |
78746 |
K181141 |
Apollo Endosurgery |
1120 S. Capital of Texas Hwy Ste. 300
| Austin |
TX |
78746 |
K171886 |
Apollo Endosurgery Inc |
1120 S. Capital of Texas Hwy. Ste 300
| Austin |
TX |
78746 |
K231553 |
Apollo Endosurgery Inc. |
1120 South Capital of Texas Hwy., Suite 300
| Austin |
TX |
78746 |
K210266 |
Apollo Endosurgery Inc. |
1120 South Capital of Texas Hwy., Suite 300
| Austin |
TX |
78746 |
K081853 |
APOLLO ENDOSURGERY, INC. |
7000 BEE CAVES RD. SUITE 350
| AUSTIN |
TX |
78746 |
K062244 |
ARTHROCARE CORP. |
27130 A PASEO ESPADA
| SAN JUAN CAPISTRANO |
CA |
92675 |
K070671 |
ARTHROCARE CORP. |
15285 ALTON PARKWAY, #200
| IRVINE |
CA |
92618 |
K103412 |
AXIOM TECHNOLOGY PARTNERS, LLC |
2939 ALHAMBRA DRIVE
| BELMONT |
CA |
94002 |
K110829 |
BAROSENSE, INC |
250 CHESAPEAKE DRIVE
| REDWOOD CITY |
CA |
94063 |
K120147 |
BAROSENSE, INC |
250 CHESAPEAKE DRIVE
| REDWOOD CITY |
CA |
94063 |
K082044 |
BAROSENSE, INC |
3698-C HAVEN AVENUE
| REDWOOD CITY |
CA |
94063 |
K090470 |
COVIDIEN |
60 MIDDLETWON DR
| NORTH HAVEN |
CT |
06473 |
K082659 |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
60 MIDDLETOWN AVENUE
| NORTH HAVEN |
CT |
06473 |
K090419 |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
60 MIDDLETOWN AVENUE
| NORTH HAVEN |
CT |
06473 |
K211309 |
Endo Tools Therapeutics S.A. |
Rue Auguste Piccard 48
| Gosselies |
|
6041 |
K073644 |
ENDOGASTRIC SOLUTIONS, INC. |
8210 154TH AVE. NE
| REDMOND |
WA |
98052 |
K091832 |
ENDOGASTRIC SOLUTIONS, INC. |
8210 154TH AVE. NE
| REDMOND |
WA |
98052 |
K062875 |
ENDOGASTRIC SOLUTIONS, INC. |
8210 154TH AVE. NE
| REDMOND |
WA |
98052 |
K033269 |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD.
| CINCINNATI |
OH |
45242-2839 |
K961390 |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD.
| CINCINNATI |
OH |
45242-2839 |
K002398 |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD.
| CINCINNATI |
OH |
45242-2839 |
K980815 |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD.
| CINCINNATI |
OH |
45242-2839 |
K970720 |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD.
| CINCINNATI |
OH |
45242-2839 |
K061770 |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD.
| CINCINNATI |
OH |
45242-2839 |
K070151 |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD
| CINCINNATI |
OH |
45242 |
K213271 |
Health Value Creation BV, trading as Corporis Medical |
Oxfordlaan 55
| Maastricht |
|
6229 EV |
K973313 |
INNOVASIVE DEVICES, INC. |
734 FOREST ST.
| MARLBOROUGH |
MA |
01752 |
K160117 |
Medeon Biodesign, Inc |
7F, 116, HouGang St
| Taipei |
|
11170 |
K193652 |
Medeon Biodesign, Inc. |
7F, 116, HouGang St.,
| Taipei |
|
11170 |
K070686 |
MINI LAP TECHNOLOGIES INC. |
543 LONG HILL AVE.
| SHELTON |
CT |
06484 |
K070352 |
MINI LAP TECHNOLOGIES INC. |
543 LONG HILL AVE.
| SHELTON |
CT |
06484 |
K101101 |
MINI LAP TECHNOLOGIES INC. |
80 SHELTON TECHNOLOGY CENTER
| SHELTON |
CT |
06484 |
K132232 |
MINILAP TECHNOLOGIES |
145 PALISADE STREET
| DOBBS FERRY |
NY |
10522 |
K160149 |
MIRET SURGICAL INC. |
205 E. BUTTERFIELD ROAD, SUITE 457
| ELMHURST |
IL |
60126 |
K073671 |
NDO SURGICAL, INC. |
125 HIGH ST.,
| MANSFIELD |
MA |
02048 |
K030170 |
OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924
| SAN JUAN CAPISTRANO |
CA |
92675 |
K023843 |
OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924
| SAN JUAN CAPISTRANO |
CA |
92675 |
K033317 |
OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924
| SAN JUAN CAPISTRANO |
CA |
92675 |
K022229 |
OPUS MEDICAL, INC. |
27127 CALLE ARROYO, SUITE 1924
| SAN JUAN CAPISTRANO |
CA |
92675 |
K003102 |
PARE SURGICAL, INC. |
7332 SOUTH ALTON WAY, UNIT H
| ENGLEWOOD |
CO |
80112 |
K971939 |
SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD.
| MANSFIELD |
MA |
02048 |
K991500 |
SMITH & NEPHEW ENDOSCOPY, INC. |
130 FORBES BLVD.
| MANSFIELD |
MA |
02048 |
K000717 |
SMITH & NEPHEW, INC. |
130 FORBES BLVD.
| MANSFIELD |
MA |
02048 |
K994087 |
SUTURA, INC. |
17080 NEWHOPE ST.
| FOUNTAIN VALLEY |
CA |
92708 |
K172666 |
SutureEase, Inc. |
1735 N First Street, Suite 300
| San Jose |
CA |
95112 |
K172775 |
Teleflex Medical, Inc. |
3015 Carrington Mill Blvd
| Morrisville |
NC |
27560 |
K132362 |
Teleflex Medical, Inc. |
2917 WECK DR.
| RESEARCH TRIANGLE PARK |
NC |
27709 |
K963999 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K960011 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE.
| NORWALK |
CT |
06856 |
K974137 |
UROMED CORP. |
64 A ST.
| NEEDHAM |
MA |
02194 |
K102931 |
USGI MEDICAL |
1140 CALLE CORDILLERA
| SAN CLEMENTE |
CA |
92673 |
|
|