ESSENTIAL SHAVER SYSTEM— 510(k) K974232

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K974232 for ESSENTIAL SHAVER SYSTEM, Substantially Equivalent on 1998-01-12. Applicant: Gyrus Ent LLC.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code EQJ
Advisory panel: Ear, Nose, Throat
Date received: 1997-11-12
Decision date: 1998-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EQJ

product code EQJ

Malfunction: 1,552
Total: 1,552

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.