ESSENTIAL SHAVER SYSTEM— 510(k) K974232
Substantially EquivalentGyrus Ent LLC
FDA 510(k) clearance K974232 for ESSENTIAL SHAVER SYSTEM, Substantially Equivalent on 1998-01-12. Applicant: Gyrus Ent LLC. Device class: 1.
Clearance details
- Applicant
- Gyrus Ent LLC
- Product code
- Code EQJ
- Device class
- Class 1
- Regulation
- 21 CFR 874.4140
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
Recent devices under product code EQJ
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- K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
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- K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
- K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
Adverse events under product code EQJ
product code EQJ- Malfunction
- 1,552
- Total
- 1,552
Source: openFDA MAUDE database, through . 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.