FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESSENTIAL SHAVER SYSTEM
K Number: K974232
·
Decision Jan 12, 1998
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
17
Applicant Total
28
Review Days
61
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Basic Information
- Device Name
- ESSENTIAL SHAVER SYSTEM
- K Number
- K974232
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4140
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Ent LLC
- Date Received
- November 12, 1997
- Decision Date
- January 12, 1998
- Product Code
- EQJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Gyrus Ent LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | Aug 20, 2004 | Substantially Equivalent |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | Mar 3, 2004 | Substantially Equivalent |
| K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM | Feb 5, 2004 | Substantially Equivalent |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | Nov 24, 2003 | Substantially Equivalent |
| K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | May 2, 2003 | Substantially Equivalent |
| K021595 | GYRUS ENT NERVE STIMULATOR | Oct 24, 2002 | Substantially Equivalent |
| K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | Aug 26, 2002 | Substantially Equivalent |
| K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 | May 28, 2002 | Substantially Equivalent |
| K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | Apr 4, 2002 | Substantially Equivalent |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | Mar 8, 2002 | Substantially Equivalent |