Endocare, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Endocare, Inc.” (first 1996, latest 2010), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 13 | 13 |
| KOD | Catheter, Urological | 2 | 2 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 2 | 2 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
| LKY | Device, External Penile Rigidity | 1 | 1 |
Review panels
- General and Plastic Surgery (15)
- Gastroenterology and Urology (4)
- Cardiovascular (2)
- General Hospital (1)
Most recent Endocare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101333 | CRYOCARE CS SURGICAL SYSTEM | GEH | 2010-06-14 | 33 |
| K062175 | CRYOCARE CN2 SYSTEM | GEH | 2006-08-28 | 28 |
| K060279 | CRYOCARE CS SURGICAL SYSTEM | GEH | 2006-02-28 | 26 |
| K050347 | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM | GEH | 2005-02-25 | 14 |
| K032333 | CRYOCARE CS SURGICAL SYSTEM | GEH | 2003-08-12 | 14 |
| K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 | GEH | 2002-12-05 | 27 |
| K021010 | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE | OCL | 2002-06-06 | 69 |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | LKY | 2002-02-05 | 26 |
| K011074 | CRYOCARE SURGICAL SYSTEM | GEH | 2002-01-25 | 291 |
| K003811 | CRYOCARE SURGICAL SYSTEM | GEH | 2001-10-11 | 304 |
12 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-10-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Endocare, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Endocare, Inc.” (first 1996, latest 2010), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endocare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endocare, Inc. is 68 days.
Which FDA product codes appear under Endocare, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 13); KOD (Catheter, Urological, 2); OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, 2).
Next steps
- See all 22 Endocare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Endocare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.