Product code GAO
- Device name
- Suture, Nonabsorbable
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4495
- 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 |
|---|---|---|---|
| N12815S023 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1988-12-22 |
| N12815S022 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1987-08-28 |
| N12815S021 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1987-06-18 |
| N12815S020 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1986-06-20 |
| N12815S019 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1984-03-29 |
| N12815S017 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1983-11-03 |
| N12815S018 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1983-09-28 |
| N12815S016 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1983-07-05 |
| N12815S015 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1983-06-07 |
| N12815S013 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1982-11-15 |
| N12815S014 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1982-07-21 |
| N12815S012 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1981-08-11 |
| N12815S002 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1981-07-07 |
| N12815S011 | MERSILENE*POLYESTER SUTURE | ETHICON, Inc. | 1981-01-06 |
| N12815S001 | MERSILENE POLYESTER SUTURE | ETHICON, Inc. | 1981-01-06 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Alto Development Corp. | 1994-01-07 |
| K872532 | AUTO SUTURE STAINLESS STEEL SUTURES* | United States Surgical, A Division of Tyco Healthc | 1987-08-05 |
| K863034 | SHARPOINT STAINLESS STEEL SUTURE | Chathamborough Research Group, Inc. | 1986-09-30 |
| K802248 | DISARP ORIGINAL | Unoplast A/S | 1980-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10195594085070 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-06-04 |
| 10841291101239 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101376 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101369 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101352 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101345 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101338 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101321 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101314 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101307 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101291 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101284 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101277 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101260 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101253 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101246 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101222 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101215 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101208 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101192 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101185 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101178 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101161 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101154 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101147 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101130 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101123 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101116 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101109 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |
| 10841291101093 | Myo/Wire II | A & E MEDICAL CORPORATION | 2015-09-15 |