K180321 is an FDA 510(k) clearance for the Aesculap Optilene Nonabsorbable Suture. This device is classified as a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II - Special Controls, product code GAW).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on March 7, 2018, 30 days after receiving the submission on February 5, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K180321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2018 |
| Decision Date | March 07, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAW — Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5010 |