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FDA 510(k)

Weck Auto Endo10 Automatic Endoscopic Clip Applier

K-Number: K161758 · 2016-09-07

Decision Date2016-09-07
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Weck Auto Endo10 Automatic Endoscopic Clip Applier is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2016-09-07 under approval number K161758. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Weck Auto Endo10 Automatic Endoscopic Clip Applier?

Weck Auto Endo10 Automatic Endoscopic Clip Applier is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Teleflex Medical. The 510(k) number is K161758.

When was Weck Auto Endo10 Automatic Endoscopic Clip Applier approved by the FDA?

Weck Auto Endo10 Automatic Endoscopic Clip Applier received FDA 510(k) clearance on 2016-09-07, under approval number K161758.

What company makes Weck Auto Endo10 Automatic Endoscopic Clip Applier?

Weck Auto Endo10 Automatic Endoscopic Clip Applier is manufactured by Teleflex Medical.

What is the FDA product code for Weck Auto Endo10 Automatic Endoscopic Clip Applier?

The FDA product code for Weck Auto Endo10 Automatic Endoscopic Clip Applier is FZP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.