AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM— 510(k) K083839

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K083839 for AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM, Substantially Equivalent on 2009-01-15. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2008-12-23
Decision date: 2009-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Covington, GA, US

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Adverse events under product code OTP

product code OTP

Injury: 1,061
Total: 1,061

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.