K192420 is an FDA 510(k) clearance for the Crownjun Nylon Suture, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Kono Seisakusho Co., Ltd. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on May 29, 2020, 268 days after receiving the submission on September 4, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K192420 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 04, 2019 |
| Decision Date | May 29, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAR — Suture, Nonabsorbable, Synthetic, Polyamide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5020 |