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FDA 510(k)

WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT

K-Number: K121380 · 2012-05-25

ApplicantTeleflexmedical, Inc.
Decision Date2012-05-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K121380. 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 WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT?

WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K121380.

When did WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT receive FDA 510(k) clearance?

WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT received FDA 510(k) clearance on 2012-05-25, under 510(k) number K121380.

Who is the listed applicant for WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT?

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 VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT?

The FDA product code for WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT 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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