FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CRYOMINI
K Number: K080735
·
Decision Apr 4, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
12
Review Days
18
Basic Information
- Device Name
- CRYOMINI
- K Number
- K080735
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZIMMER ELEKTROMEDIZIN GMBH
- Date Received
- March 17, 2008
- Decision Date
- April 4, 2008
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ZIMMER ELEKTROMEDIZIN GMBH
| K Number | Device Name | ||
|---|---|---|---|
| K060395 | CRYO, MODEL V6.0 | Feb 24, 2006 | Substantially Equivalent |
| K040727 | CRYO 5 | Apr 23, 2004 | Substantially Equivalent |
| K960969 | GALVA 5-T | May 15, 1996 | Substantially Equivalent |
| K952536 | SONO 5 | Mar 5, 1996 | Substantially Equivalent for Some Indications |
| K954411 | GALVA-5-M | Feb 28, 1996 | Substantially Equivalent for Some Indications |
| K924473 | DISPOSABLE THERAPY ELECTRODE | May 19, 1993 | Substantially Equivalent |
| K860758 | VACO SUCTION ELECTRODE UNIT | May 2, 1986 | Substantially Equivalent |
| K850006 | TENS | Dec 20, 1985 | Substantially Equivalent for Some Indications |
| K852166 | THERMO SHORTWAVE DIATHERMY | Sep 30, 1985 | Substantially Equivalent for Some Indications |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 7, 1985 | Substantially Equivalent |