REPROCESSED ENT SHAVERS— 510(k) K081814

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K081814 for REPROCESSED ENT SHAVERS, Substantially Equivalent on 2008-12-17. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2008-06-26
Decision date: 2008-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.