FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAMED RF GENERATOR DATA RECORDER
K Number: K963180
·
Decision Oct 10, 1996
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
57
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Basic Information
- Device Name
- VIDAMED RF GENERATOR DATA RECORDER
- K Number
- K963180
- 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
- Vidamed, Inc.
- Date Received
- August 14, 1996
- Decision Date
- October 10, 1996
- 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 Vidamed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K014224 | PRECISION PLUS TUNA OFFICE SYSTEM | Jan 23, 2002 | Substantially Equivalent |
| K012587 | RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE | Dec 11, 2001 | Substantially Equivalent |
| K011787 | PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE | Jul 6, 2001 | Substantially Equivalent |
| K002583 | TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM | Feb 13, 2001 | Substantially Equivalent |
| K973366 | COBRA HAND PIECE | Nov 26, 1997 | Substantially Equivalent |
| K965199 | TUNA 5 CATHETER | Apr 30, 1997 | Substantially Equivalent |
| K965061 | VIDAMED MODEDL 7600 RF GENERATOR | Jan 28, 1997 | Substantially Equivalent |
| K960918 | VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM | Oct 8, 1996 | Substantially Equivalent |
| K955035 | VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR | Nov 29, 1995 | Substantially Equivalent |
| K951245 | VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY | Jun 9, 1995 | Substantially Equivalent |