K863595 is an FDA 510(k) clearance for the COATED SUTURE NEEDLE. This device is classified as a Needle, Suturing, Disposable (Class I - General Controls, product code GAB).
Submitted by Sharpoint, Inc. (Reading, US). The FDA issued a Cleared decision on October 24, 1986, 39 days after receiving the submission on September 15, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K863595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1986 |
| Decision Date | October 24, 1986 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAB — Needle, Suturing, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |