MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY— 510(k) K022879
Substantially EquivalentSanarus Medical, Inc.
FDA 510(k) clearance K022879 for MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY, Substantially Equivalent on 2002-09-23. 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
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code KNW
view allMore 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
- K061510 — SANARUS VISICA TREATMENT SYSTEM
- K052861 — MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
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.