FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYOMEDICS 5000 CRYOPROBES
K Number: K832140
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
17
Review Days
45
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Basic Information
- Device Name
- CRYOMEDICS 5000 CRYOPROBES
- K Number
- K832140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Spembly Medical , Ltd.
- Date Received
- June 28, 1983
- Decision Date
- August 12, 1983
- Product Code
- GEH
- 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Spembly Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K925129 | SELECTOR | Apr 23, 1993 | Substantially Equivalent |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Oct 11, 1990 | Substantially Equivalent |
| K901974 | SELECTOR ULTRASONIC SURGICAL ASPIRATOR | Sep 5, 1990 | Substantially Equivalent |
| K882568 | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY | Sep 27, 1988 | Substantially Equivalent |
| K882962 | SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) | Aug 8, 1988 | Substantially Equivalent |
| K882963 | SPEMBLY MEDICAL 142 CRYO UNIT | Aug 8, 1988 | Substantially Equivalent |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Jan 4, 1988 | Substantially Equivalent |
| K840497 | OBSTETRIC PULSAR TWO CHANNEL TENS | Apr 16, 1984 | Substantially Equivalent |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | Sep 12, 1983 | Substantially Equivalent |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | Aug 12, 1983 | Substantially Equivalent |