SANARUS INDICA MARKER SYSTEM— 510(k) K020054
Substantially EquivalentSanarus Medical, Inc.
FDA 510(k) clearance K020054 for SANARUS INDICA MARKER SYSTEM, Substantially Equivalent on 2002-10-16. Applicant: Sanarus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sanarus Medical, Inc.
- Product code
- Code FZP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code FZP
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 FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
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.