FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
K Number: K021777
·
Decision Aug 26, 2002
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
28
Review Days
88
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Basic Information
- Device Name
- GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
- K Number
- K021777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Ent LLC
- Date Received
- May 30, 2002
- Decision Date
- August 26, 2002
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| K003214 | SMITH & NEPHEW PISTONS | Oct 31, 2000 | Substantially Equivalent |