K862696 is an FDA 510(k) clearance for the TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP. This device is classified as a Applier, Hemostatic Clip (Class I - General Controls, product code HBT).
Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on July 30, 1986, 15 days after receiving the submission on July 15, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K862696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1986 |
| Decision Date | July 30, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HBT — Applier, Hemostatic Clip |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |