K013747 is an FDA 510(k) clearance for the TEKNO-MEDICAL OBSTETRICAL FORCEPS. This device is classified as a Forceps, Obstetrical (Class II — Special Controls, product code HDA).
Submitted by Tekno Medical Optik-Chirurgie GmbH & Co. (Tuningen, B.W., DE). The FDA issued a Cleared decision on February 11, 2002, 90 days after receiving the submission on November 13, 2001.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4400.
| 510(k) Number | K013747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2001 |
| Decision Date | February 11, 2002 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDA — Forceps, Obstetrical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4400 |