AJUST ADJUSTABLE SINGLE INCISION SLING— 510(k) K092607

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K092607 for AJUST ADJUSTABLE SINGLE INCISION SLING, Substantially Equivalent on 2009-11-20. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2009-08-25
Decision date: 2009-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

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.