BLUE SUI SLING— 510(k) K121754

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K121754 for BLUE SUI SLING, Substantially Equivalent on 2012-10-10. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2012-06-14
Decision date: 2012-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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.