K801660 is an FDA 510(k) clearance for the PROXIMATE * PSD PURSE-STRING DEVICE. This device is classified as a Clamp, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDJ).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980, 23 days after receiving the submission on July 21, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K801660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1980 |
| Decision Date | August 13, 1980 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDJ — Clamp, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |