FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
K Number: K964594
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
6
Review Days
273
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Basic Information
- Device Name
- VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
- K Number
- K964594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Circon Corp.
- Date Received
- November 15, 1996
- Decision Date
- August 15, 1997
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Circon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K992544 | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM | Oct 26, 1999 | Substantially Equivalent |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Aug 3, 1999 | Substantially Equivalent |
| K981611 | SNAP-N-PEEL INTRODUCERS | Jul 30, 1998 | Substantially Equivalent |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Jun 12, 1998 | Substantially Equivalent |
| K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | May 12, 1998 | Substantially Equivalent |