510(k) Report

FDA applicant

Endocare, Inc.

Irvine, CA22 decisions1996–20105 recalls

FDA records 22 decisions for Endocare, Inc. (Irvine, CA) from 1996 to 2010: 22 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and OCL (Surgical Device, For Cutting, Coagulation…). Its devices cite 23 predicates, 9 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Endocare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2012

2008: 22010: 12012: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Endocare, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Endocare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEHUnit, Cryosurgical, Accessories13decisions
  • OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac…2decisions
  • KODCatheter, Urological2decisions
  • FLLContinuous Measurement Thermometer1decision
  • LKYDevice, External Penile Rigidity1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Also: KNW (1), FAS (1).

Whose devices does it build on?

Its devices cite 23 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011040Cryocare Cardiac Surgical SystemEndocare, Inc. · 20015cite it
  • K021010Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc. · 20023cite it
  • K011074Cryocare Surgical SystemEndocare, Inc. · 20023cite it
  • K003811Cryocare Surgical SystemEndocare, Inc. · 20013cite it
  • K032333Cryocare CS Surgical SystemEndocare, Inc. · 20032cite it
  • K961365Endocare Electornic Thermometer SystemEndocare, Inc. · 19962cite it

What has FDA decided for it lately?

  • K101333Cryocare CS Surgical SystemEndocare, Inc. · 20102 recalls
  • K062175Cryocare CN2 SystemEndocare, Inc. · 2006
  • K060279Cryocare CS Surgical SystemEndocare, Inc. · 20063 recalls
  • K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
  • K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003
  • K023757Cryocare Surgical System, Model Cryo 20Endocare, Inc. · 20022 recalls
  • K021010Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc. · 2002
  • K020082Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery SystemEndocare, Inc. · 2002

All 22 as Endocare, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K101333HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an…Dec 20, 2012Class II
  • K101333CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter…Feb 27, 2012
  • K060279Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751.…Nov 4, 2010
  • K011074V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a…Dec 5, 2008
  • K011074V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally…Dec 5, 2008