Submission Details
| 510(k) Number | K011532 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 18, 2001 |
| Decision Date | July 30, 2001 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
MITYVAC
Jul 2001
Decision
73d
Days
Class 2
Risk
About This 510(k) Submission
K011532 is an FDA 510(k) clearance for the MITYVAC, a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Prism Enterprises, Inc. (Washington, US). The FDA issued a Cleared decision on July 30, 2001, 73 days after receiving the submission on May 18, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.
Device Classification
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4340 |
Manufacturer
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