K012199 is an FDA 510(k) clearance for the DIGICAP. This device is classified as a Needle, Suturing, Disposable (Class I - General Controls, product code GAB).
Submitted by Humana USA, Inc. (Bethesda, US). The FDA issued a Cleared decision on December 19, 2001, 159 days after receiving the submission on July 13, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K012199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2001 |
| Decision Date | December 19, 2001 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | GAB — Needle, Suturing, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |