K915119 is an FDA 510(k) clearance for the SCALPEL BLADE REMOVER (BLADEGARD). This device is classified as a Blade, Scalpel (Class I - General Controls, product code GES).
Submitted by Intergrated Visual, Inc. (Quincy, US). The FDA issued a Cleared decision on May 5, 1992, 174 days after receiving the submission on November 13, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K915119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1991 |
| Decision Date | May 05, 1992 |
| Days to Decision | 174 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 |