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FDA 510(k)

ENDOCARE PERCUTANEOUS ACCESS SET

K-Number: K010339 · 2001-03-07

ApplicantEndocare, Inc.
Decision Date2001-03-07
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOCARE PERCUTANEOUS ACCESS SET is the device name listed in this FDA 510(k) record. The listed applicant is Endocare, Inc.. It received FDA 510(k) clearance on 2001-03-07 under 510(k) number K010339. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCARE PERCUTANEOUS ACCESS SET?

ENDOCARE PERCUTANEOUS ACCESS SET is a medical device that received FDA 510(k) clearance on 2001-03-07. The listed applicant is Endocare, Inc.. The 510(k) number is K010339.

When did ENDOCARE PERCUTANEOUS ACCESS SET receive FDA 510(k) clearance?

ENDOCARE PERCUTANEOUS ACCESS SET received FDA 510(k) clearance on 2001-03-07, under 510(k) number K010339.

Who is the listed applicant for ENDOCARE PERCUTANEOUS ACCESS SET?

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 ENDOCARE PERCUTANEOUS ACCESS SET?

The FDA product code for ENDOCARE PERCUTANEOUS ACCESS SET is KOD.

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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: KOD)

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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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