SURGICAL DRILL-ELECTRIC-HANDPIECE— 510(k) K831946

Substantially Equivalent

Entronics

FDA 510(k) clearance K831946 for SURGICAL DRILL-ELECTRIC-HANDPIECE, Substantially Equivalent on 1983-11-03. Applicant: Entronics.

Clearance details

Applicant: Entronics
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1983-06-16
Decision date: 1983-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.