MITYVAC— 510(k) K011532

Substantially Equivalent

Prism Enterprises, Inc.

FDA 510(k) clearance K011532 for MITYVAC, Substantially Equivalent on 2001-07-30. Applicant: Prism Enterprises, Inc..

Clearance details

Applicant: Prism Enterprises, Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 2001-05-18
Decision date: 2001-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.