TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;— 510(k) K992994

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K992994 for TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;, Substantially Equivalent on 1999-11-23. Applicant: Gyrus Ent LLC.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1999-09-07
Decision date: 1999-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, 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.