FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBRA HAND PIECE
K Number: K973366
·
Decision Nov 26, 1997
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
11
Review Days
79
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Basic Information
- Device Name
- COBRA HAND PIECE
- K Number
- K973366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vidamed, Inc.
- Date Received
- September 8, 1997
- Decision Date
- November 26, 1997
- Product Code
- KNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.
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Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
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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 |
| K965199 | TUNA 5 CATHETER | Apr 30, 1997 | Substantially Equivalent |
| K965061 | VIDAMED MODEDL 7600 RF GENERATOR | Jan 28, 1997 | Substantially Equivalent |
| K963180 | VIDAMED RF GENERATOR DATA RECORDER | Oct 10, 1996 | 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 |