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FDA 510(k)

WECK EFX ENDO FASCIAL CLOSURE SYSTEM

K-Number: K132362 · 2013-10-08

ApplicantTeleflexmedical, Inc.
Decision Date2013-10-08
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WECK EFX ENDO FASCIAL CLOSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2013-10-08 under 510(k) number K132362. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WECK EFX ENDO FASCIAL CLOSURE SYSTEM?

WECK EFX ENDO FASCIAL CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K132362.

When did WECK EFX ENDO FASCIAL CLOSURE SYSTEM receive FDA 510(k) clearance?

WECK EFX ENDO FASCIAL CLOSURE SYSTEM received FDA 510(k) clearance on 2013-10-08, under 510(k) number K132362.

Who is the listed applicant for WECK EFX ENDO FASCIAL CLOSURE SYSTEM?

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

What is the FDA product code for WECK EFX ENDO FASCIAL CLOSURE SYSTEM?

The FDA product code for WECK EFX ENDO FASCIAL CLOSURE SYSTEM is OCW.

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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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