K832138 is an FDA 510(k) clearance for the BIOMER * PLEDGET SUTURE BUTTRESS. This device is classified as a Retention Device, Suture (Class I - General Controls, product code KGS).
Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on May 23, 1984, 327 days after receiving the submission on July 1, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K832138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1983 |
| Decision Date | May 23, 1984 |
| Days to Decision | 327 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4930 |