FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZZIPP INSTANT BOVIE CLEANER
K Number: K900714
·
Decision Mar 27, 1990
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
15
Review Days
41
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Basic Information
- Device Name
- ZZIPP INSTANT BOVIE CLEANER
- K Number
- K900714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Grieshaber & Co.
- Date Received
- February 14, 1990
- Decision Date
- March 27, 1990
- 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 Grieshaber & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K950056 | THE GRIESHABER AXIAL CUTTER | May 5, 1995 | Substantially Equivalent |
| K930842 | THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE | May 3, 1994 | Substantially Equivalent |
| K914588 | GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE | Jun 11, 1992 | Substantially Equivalent |
| K914587 | GRIESHABER AIR/FLUID TUBING SET | Jan 23, 1992 | Substantially Equivalent |
| K914585 | GRIESHABER TWO FUNCTION MANIPULATOR | Jan 3, 1992 | Substantially Equivalent |
| K914586 | GRIESHABER THREE FUNCTION MANIPULATOR | Jan 3, 1992 | Substantially Equivalent |
| K897119 | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | Apr 12, 1990 | Substantially Equivalent |
| K890782 | GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) | Jun 23, 1989 | Substantially Equivalent |
| K890783 | GRIESHABER VISCOELASTIC INJECTION SYSTEM | May 16, 1989 | Substantially Equivalent |
| K884043 | GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE | Nov 16, 1988 | Substantially Equivalent |