FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
K Number: K052861
·
Decision Nov 15, 2005
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
14
Review Days
35
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Basic Information
- Device Name
- MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
- K Number
- K052861
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sanarus Medical, Inc.
- Date Received
- October 11, 2005
- Decision Date
- November 15, 2005
- 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 Sanarus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080171 | SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 | Mar 6, 2008 | Substantially Equivalent |
| K073533 | SANARUS V2 TREATMENT SYSTEM | Feb 7, 2008 | Substantially Equivalent |
| K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 | Jan 3, 2007 | Substantially Equivalent |
| K061510 | SANARUS VISICA TREATMENT SYSTEM | Jul 18, 2006 | Substantially Equivalent |
| K051581 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | Jul 27, 2005 | Substantially Equivalent |
| K042136 | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM | Sep 8, 2004 | Substantially Equivalent |
| K032506 | SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM | Oct 9, 2003 | Substantially Equivalent |
| K020054 | SANARUS INDICA MARKER SYSTEM | Oct 16, 2002 | Substantially Equivalent |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | Oct 15, 2002 | Substantially Equivalent |
| K022879 | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY | Sep 23, 2002 | Substantially Equivalent |