K895682 is an FDA 510(k) clearance for the VESSEL LOOPS. This device is classified as a Scalpel, One-piece (Class I - General Controls, product code GDX).
Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on October 24, 1989, 33 days after receiving the submission on September 21, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K895682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1989 |
| Decision Date | October 24, 1989 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDX — Scalpel, One-piece |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |