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FDA 510(k)

Weck Auto Endo10 Automatic Endoscopic Clip Applier

K-Number: K161758 · 2016-09-07

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

Device Summary

Weck Auto Endo10 Automatic Endoscopic Clip Applier is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2016-09-07 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K161758.

When did Weck Auto Endo10 Automatic Endoscopic Clip Applier receive FDA 510(k) clearance?

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

Who is the listed applicant for Weck Auto Endo10 Automatic Endoscopic Clip Applier?

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

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.

Other records listing Teleflex Medical as applicant

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Related Devices (Code: FZP)

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.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter Int

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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