FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CMS ONCOPROBE (TM)
K Number: K904421
·
Decision Apr 8, 1991
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
250
Applicant Total
10
Review Days
193
Basic Information
- Device Name
- CMS ONCOPROBE (TM)
- K Number
- K904421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- CRYOMEDICAL SCIENCES, INC.
- Date Received
- September 27, 1990
- Decision Date
- April 8, 1991
- 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 CRYOMEDICAL SCIENCES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K011073 | CRYOPLAN SYSTEM | Aug 22, 2001 | Substantially Equivalent |
| K982055 | ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 | Sep 8, 1998 | Substantially Equivalent |
| K980668 | CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 | Jul 17, 1998 | Substantially Equivalent |
| K980670 | CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 | Jul 17, 1998 | Substantially Equivalent |
| K973190 | ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES | Nov 21, 1997 | Substantially Equivalent |
| K970995 | CMS CRYOLITE | Jul 7, 1997 | Substantially Equivalent |
| K964336 | CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 | Mar 20, 1997 | Substantially Equivalent |
| K953637 | CMS ACCUPROBE 550/530 | Dec 4, 1995 | Substantially Equivalent |
| K952895 | CMS URETHRAL WARMER | Oct 24, 1995 | Substantially Equivalent |