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 |
| K231240 | Covidien |
60 Middletown Avenue | 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 |
| K243750 | Envision Endoscopy |
204 Second Ave, 2nd Floor | Waltham | MA | 02451 |
| 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 |
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