Cleared Traditional

K161758 - Weck Auto Endo10 Automatic Endoscopic C...

K161758 is an FDA 510(k) clearance for Weck Auto Endo10 Automatic Endoscopic C..., manufactured by Teleflex Medical. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K161758 · Teleflex Medical · General & Plastic Surgery device
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Sep 2016
Decision
72d
Days
Class 2
Risk

K161758 is an FDA 510(k) clearance for the Weck Auto Endo10 Automatic Endoscopic Clip Applier. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on September 7, 2016 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teleflex Medical devices

FDA 510(k) Submission Details - K161758

510(k) Number K161758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date September 07, 2016
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 104
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K161758.
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
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AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · AtriCure, Inc. · Oct 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
K163261 · AtriCure, Inc. · May 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · AtriCure, Inc. · Mar 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500 · AtriCure, Inc. · Jan 2016
SureClip
K150936 · Conmed Corporation · Oct 2015