PREPEX SYSTEM— 510(k) K103695

Substantially Equivalent

Circ Medtech

FDA 510(k) clearance K103695 for PREPEX SYSTEM, Substantially Equivalent on 2012-01-10. Applicant: Circ Medtech.

Clearance details

Applicant: Circ Medtech
Product code: Code HFX
Advisory panel: Obstetrics/Gynecology
Date received: 2010-12-17
Decision date: 2012-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chalotte, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HFX

product code HFX

Other: 3
Total: 3

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.