K914244 is an FDA 510(k) clearance for the STERILE CUSTOM SURGICAL KITS. This device is classified as a Kit, Surgical Instrument, Disposable (Class I - General Controls, product code KDD).
Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on February 24, 1992, 154 days after receiving the submission on September 23, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K914244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | September 23, 1991 |
| Decision Date | February 24, 1992 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KDD — Kit, Surgical Instrument, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |