K831648 is an FDA 510(k) clearance for the ANCHOR BRAND SURGICAL NEEDLES. This device is classified as a Needle, Suturing, Disposable (Class I - General Controls, product code GAB).
Submitted by Anchor Products Co. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983, 85 days after receiving the submission on May 23, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K831648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1983 |
| Decision Date | August 16, 1983 |
| Days to Decision | 85 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 |