SANARUS VISICA TREATMENT SYSTEM— 510(k) K061510
Substantially EquivalentSanarus Medical, Inc.
FDA 510(k) clearance K061510 for SANARUS VISICA TREATMENT SYSTEM, Substantially Equivalent on 2006-07-18. Applicant: Sanarus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sanarus Medical, Inc.
- Product code
- Code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code GEH
view all- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
More clearances from Sanarus Medical, Inc.
view all- K080171 — SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
- K073533 — SANARUS V2 TREATMENT SYSTEM
- K062896 — V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
- K052861 — MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
- K051581 — SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.