K011621 is an FDA 510(k) clearance for the KOALA CLAMP, KOALA CLAMP AND CUTTER. This device is classified as a Clamp, Umbilical (Class II - Special Controls, product code HFW).
Submitted by Maternus, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 10, 2001, 77 days after receiving the submission on May 25, 2001.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K011621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2001 |
| Decision Date | August 10, 2001 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFW — Clamp, Umbilical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |