Company ยท US
Endocare, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2010. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 14 |
| KOD | Catheter, Urological | 2 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 2 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| KNW | Instrument, Biopsy | 1 |
| LKY | Device, External Penile Rigidity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2010 | K101333 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. | GEH |
| Aug 28, 2006 | K062175 | CRYOCARE CN2 SYSTEM Endocare, Inc. | GEH |
| Feb 28, 2006 | K060279 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. | GEH |
| Feb 25, 2005 | K050347 | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. | GEH |
| Aug 12, 2003 | K032333 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. | GEH |
| Dec 5, 2002 | K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 Endocare, Inc. | GEH |
| Jun 6, 2002 | K021010 | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE Endocare, Inc. | OCL |
| Feb 5, 2002 | K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM Endocare, Inc. | LKY |
| Jan 25, 2002 | K011074 | CRYOCARE SURGICAL SYSTEM Endocare, Inc. | GEH |
| Oct 11, 2001 | K003811 | CRYOCARE SURGICAL SYSTEM Endocare, Inc. | GEH |
| Jun 15, 2001 | K011040 | CRYOCARE CARDIAC SURGICAL SYSTEM Endocare, Inc. | OCL |
| May 3, 2001 | K003528 | SANARUS CORE TISSUE BIOPSY SYSTEM Endocare, Inc. | KNW |
| Mar 7, 2001 | K010339 | ENDOCARE PERCUTANEOUS ACCESS SET Endocare, Inc. | KOD |
| Nov 13, 2000 | K002615 | SURGICAL SYSTEM WITH CRYOGUIDE Endocare, Inc. | GEH |
| Oct 13, 2000 | K002396 | ENDOCARE PERCUTANEOUS ACCESS SET Endocare, Inc. | KOD |
| Apr 10, 1998 | K980110 | ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM Endocare, Inc. | GEH |
| Dec 22, 1997 | K973686 | ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM Endocare, Inc. | GEH |
| Feb 25, 1997 | K965243 | ENDOCARE ELECTROSURGICAL ELECTRODE Endocare, Inc. | GEI |
| Feb 25, 1997 | K965118 | ENDOCARE MONOPOLAR ELECTRODE Endocare, Inc. | FAS |
| Feb 25, 1997 | K963970 | ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM Endocare, Inc. | GEH |
| Dec 18, 1996 | K963826 | ENDOCARE CRYCARE CRYOSURGICAL SYSTEM Endocare, Inc. | GEH |
| Aug 15, 1996 | K961365 | ENDOCARE ELECTORNIC THERMOMETER SYSTEM Endocare, Inc. | FLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2003 | Endocare Inc SurgiFrost Cryosurgical Probes Terminated |
GEH | None listed |