Submission Details
| 510(k) Number | K851752 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 1985 |
| Decision Date | June 20, 1985 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
K851752 - 9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS
(FDA 510(k) Clearance)
Jun 1985
Decision
56d
Days
Class 1
Risk
K851752 is an FDA 510(k) clearance for the 9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS, a Knife, Amputation (Class I — General Controls, product code GDN), submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985, 56 days after receiving the submission on April 25, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
Device Classification
| Product Code | GDN — Knife, Amputation |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |