K923170 is an FDA 510(k) clearance for the LOS ALAMOS RETRACTABLE KNIFE. This device is classified as a Blade, Scalpel (Class I - General Controls, product code GES).
Submitted by Innovative Surgical Technology, Inc. (Los Alamos, US). The FDA issued a Cleared decision on February 18, 1993, 234 days after receiving the submission on June 29, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K923170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1992 |
| Decision Date | February 18, 1993 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GES — Blade, Scalpel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |