K915763 is an FDA 510(k) clearance for the MODIFIED DISPOSABLE FETAL VACUUM. This device is classified as a Extractor, Vacuum, Fetal (Class II - Special Controls, product code HDB).
Submitted by Columbia Medical & Surgical, Inc. (Bend, US). The FDA issued a Cleared decision on March 18, 1992, 85 days after receiving the submission on December 24, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4340.
| 510(k) Number | K915763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1991 |
| Decision Date | March 18, 1992 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4340 |