Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CRYOCARE CS SURGICAL SYSTEM

K-Number: K101333 · 2010-06-14

ApplicantEndocare, Inc.
Decision Date2010-06-14
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOCARE CS SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endocare, Inc.. It received FDA 510(k) clearance on 2010-06-14 under 510(k) number K101333. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOCARE CS SURGICAL SYSTEM?

CRYOCARE CS SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-14. The listed applicant is Endocare, Inc.. The 510(k) number is K101333.

When did CRYOCARE CS SURGICAL SYSTEM receive FDA 510(k) clearance?

CRYOCARE CS SURGICAL SYSTEM received FDA 510(k) clearance on 2010-06-14, under 510(k) number K101333.

Who is the listed applicant for CRYOCARE CS SURGICAL SYSTEM?

The FDA 510(k) record lists Endocare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOCARE CS SURGICAL SYSTEM?

The FDA product code for CRYOCARE CS SURGICAL SYSTEM is GEH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Endocare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062175CRYOCARE CN2 SYSTEMK060279CRYOCARE CS SURGICAL SYSTEMK050347MODIFICATION TO CRYOCARE CS SURGICAL SYSTEMK032333CRYOCARE CS SURGICAL SYSTEMK023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20K021010MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE

View all 22 devices →

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑