Product code GAK
- Device name
- Suture, Absorbable
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4830
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N18176S015 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1987-06-18 |
| N18176S014 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1986-12-03 |
| N18175S015 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1986-12-03 |
| N18176S011 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1984-05-02 |
| N18175S012 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1984-05-02 |
| N18176S012 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1984-03-27 |
| N18175S013 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1984-03-27 |
| N18176S009 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1982-07-21 |
| N18175S010 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1982-07-21 |
| N18175S009 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1982-07-09 |
| N18176S006 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1981-09-24 |
| N18175S006 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1981-09-24 |
| N18176S008 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1981-09-21 |
| N18175S008 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1981-09-21 |
| N18176S007 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1981-08-11 |
| N18175S007 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1981-08-11 |
| N18176S004 | COATED VICRYL (POLYGLACTIN 910) | ETHICON, Inc. | 1981-07-07 |
| N18175S004 | COATED VICRYL (POLYGLACTIN 910) SUTURE (DYED) | ETHICON, Inc. | 1981-07-07 |
| N18176S005 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1981-06-11 |
| N18175S005 | CPATED VICRYL (POLYGLACTIN 910) ABSORBABLE | ETHICON, Inc. | 1981-06-11 |
| N18176S003 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1980-12-31 |
| N18175S003 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1980-12-31 |
| N18176S002 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1980-12-17 |
| N18175S002 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1980-12-17 |
| N18176S001 | COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) | ETHICON, Inc. | 1980-05-02 |
| N18175S001 | COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA | ETHICON, Inc. | 1980-05-02 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914365 | DEXON DISSECTING SPONGE | Davis & Geck, Inc. | 1991-10-23 |