SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012— 510(k) K080171
Substantially EquivalentSanarus Medical, Inc.
FDA 510(k) clearance K080171 for SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012, Substantially Equivalent on 2008-03-06. Applicant: Sanarus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sanarus Medical, Inc.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code KNW
view allMore clearances from Sanarus Medical, Inc.
view all- K073533 — SANARUS V2 TREATMENT SYSTEM
- K062896 — V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
- K061510 — SANARUS VISICA TREATMENT SYSTEM
- K052861 — MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
- K051581 — SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.