Product code GAN
- Device name
- Suture, Absorbable, Synthetic
- 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 |
|---|---|---|---|
| N17472S043 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1987-10-05 |
| N17472S042 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1987-08-28 |
| N17482S035 | VICRYL MESH | ETHICON, Inc. | 1987-06-18 |
| N17472S041 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1987-06-18 |
| N17482S034 | VICRYL MESH | ETHICON, Inc. | 1986-12-03 |
| N17472S040 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1986-12-03 |
| N17482S031 | VICRYL MESH | ETHICON, Inc. | 1984-05-02 |
| N17472S037 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1984-05-02 |
| N17482S032 | VICRYL MESH | ETHICON, Inc. | 1984-03-27 |
| N17472S038 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1984-03-27 |
| N17482S030 | VICRYL MESH | ETHICON, Inc. | 1982-07-21 |
| N17472S035 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1982-07-21 |
| N17472S036 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1982-07-09 |
| N17482S013 | VICRYL MESH | ETHICON, Inc. | 1981-12-14 |
| N17472S018 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1981-12-14 |
| N17482S029 | VICRYL MESH | ETHICON, Inc. | 1981-08-11 |
| N17472S034 | VICRYL (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1981-08-11 |
| N17482S027 | VICRYL MESH | ETHICON, Inc. | 1981-07-07 |
| N17472S032 | VICRYL (POLYGLACTIN 910)SUTURE SHYTHETIC ABSORBABL | ETHICON, Inc. | 1981-07-07 |
| N17482S028 | VICRYL (POLYGLACTIN 910) | ETHICON, Inc. | 1981-06-11 |
| N17472S033 | VICRYL (POLYGLACTIN 910) | ETHICON, Inc. | 1981-06-11 |
| N17482S023 | VICRYL MESH | ETHICON, Inc. | 1981-01-06 |
| N17472S028 | VICRLY (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | 1981-01-06 |
| N17482S001 | VICROL SYNTHETIC ABSORABLE SUTURE UNDYED | ETHICON, Inc. | 1980-12-31 |
| N17472S001 | VICRYL (POLYGLACTIN 910) SUTURE DYED | ETHICON, Inc. | 1980-12-31 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | Surgical Specialties Corp | 2000-12-15 |
| K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | ETHICON, Inc. | 1996-12-18 |
| K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | ETHICON, Inc. | 1996-03-28 |
| K951231 | ORTHOPEDIC PACKS | Sterile Concepts, Inc. | 1995-12-01 |
| K920978 | ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED | ETHICON, Inc. | 1994-02-15 |
| K895579 | POLYSORB SYNTHETIC ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | 1990-07-05 |
| K900198 | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | American Cyanamid Co. | 1990-07-05 |
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