K043614 is an FDA 510(k) clearance for the VACULINK, MODEL VCL 3000, a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Medevco, Inc. (Plano, US). The FDA issued a Cleared decision on April 14, 2005, 105 days after receiving the submission on December 30, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.
| 510(k) Number | K043614 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 2004 |
| Decision Date | April 14, 2005 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4340 |