PUBOUURETHRAL SLING— 510(k) K974098

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K974098 for PUBOUURETHRAL SLING, Substantially Equivalent on 1998-01-28. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 1997-10-30
Decision date: 1998-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.