Sanarus Medical, Inc.
Pleasanton, CA, US
Sanarus Medical, Inc. appears in FDA device records in Pleasanton, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Sanarus Medical, Inc. between 2002 and 2008. The busiest year on record is 2002, with 6. The most recent is 2008, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 6 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080171 | SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 | KNW | Substantially Equivalent | |
| K073533 | SANARUS V2 TREATMENT SYSTEM | GEH | Substantially Equivalent | |
| K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 | GEH | Substantially Equivalent | |
| K061510 | SANARUS VISICA TREATMENT SYSTEM | GEH | Substantially Equivalent | |
| K052861 | MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 | GEH | Substantially Equivalent | |
| K051581 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | KNW | Substantially Equivalent | |
| K042136 | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM | KNW | Substantially Equivalent | |
| K032506 | SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM | KNW | Substantially Equivalent | |
| K020054 | SANARUS INDICA MARKER SYSTEM | FZP | Substantially Equivalent | |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | GEH | Substantially Equivalent | |
| K022879 | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY | KNW | Substantially Equivalent | |
| K021211 | MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM | GEH | Substantially Equivalent | |
| K021137 | SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM | KNW | Substantially Equivalent | |
| K020605 | SANARUS VISICA TREATMENT SYSTEM | GEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1008-03 | Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single) | Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure. | Terminated | ||
| Z-0935-03 | Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack) | Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain