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FDA 510(k)

ENDOPATH DILATING TIP TROCAR, MODEL #512XD

K-Number: K020428 · 2002-03-04

ApplicantEthicon Endo-Surgery, Inc.
Decision Date2002-03-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOPATH DILATING TIP TROCAR, MODEL #512XD is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2002-03-04 under 510(k) number K020428. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPATH DILATING TIP TROCAR, MODEL #512XD?

ENDOPATH DILATING TIP TROCAR, MODEL #512XD is a medical device that received FDA 510(k) clearance on 2002-03-04. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K020428.

When did ENDOPATH DILATING TIP TROCAR, MODEL #512XD receive FDA 510(k) clearance?

ENDOPATH DILATING TIP TROCAR, MODEL #512XD received FDA 510(k) clearance on 2002-03-04, under 510(k) number K020428.

Who is the listed applicant for ENDOPATH DILATING TIP TROCAR, MODEL #512XD?

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

What is the FDA product code for ENDOPATH DILATING TIP TROCAR, MODEL #512XD?

The FDA product code for ENDOPATH DILATING TIP TROCAR, MODEL #512XD is GCJ.

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Related Devices (Code: GCJ)

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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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