OTOSILK— 510(k) K952203

Name: FDA 510(k) clearance K952203
Creator: U.S. Food and Drug Administration
Published: 1995-07-31

Substantially Equivalent

Boston Medical Products, Inc.

FDA 510(k) clearance K952203 for OTOSILK, Substantially Equivalent on 1995-07-31. Applicant: Boston Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Boston Medical Products, Inc.
Product code: Code NAD
Device class: Class 1
Regulation: 21 CFR 878.4020
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 ↗

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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.