OTOSILK— 510(k) K952203

Substantially Equivalent

Boston Medical Products, Inc.

FDA 510(k) clearance K952203 for OTOSILK, Substantially Equivalent on 1995-07-31. Applicant: Boston Medical Products, Inc..

Clearance details

Applicant: Boston Medical Products, Inc.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1995-05-10
Decision date: 1995-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.