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FDA 510(k)

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE

K-Number: K021010 · 2002-06-06

ApplicantEndocare, Inc.
Decision Date2002-06-06
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE is the device name listed in this FDA 510(k) record. The listed applicant is Endocare, Inc.. It received FDA 510(k) clearance on 2002-06-06 under 510(k) number K021010. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE?

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Endocare, Inc.. The 510(k) number is K021010.

When did MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE receive FDA 510(k) clearance?

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021010.

Who is the listed applicant for MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE?

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 MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE?

The FDA product code for MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE is OCL.

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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.

K101333CRYOCARE CS SURGICAL SYSTEMK062175CRYOCARE CN2 SYSTEMK060279CRYOCARE CS SURGICAL SYSTEMK050347MODIFICATION TO CRYOCARE CS SURGICAL SYSTEMK032333CRYOCARE CS SURGICAL SYSTEMK023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20

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Related Devices (Code: OCL)

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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.

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