Cleared Traditional

K142777 - Weck Hem-o-lok Auto Endo5 Ligating Clip...

K142777 is the FDA 510(k) clearance for Weck Hem-o-lok Auto Endo5 Ligating Clip... by Teleflexmedical, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K142777 · Teleflexmedical, Inc. · General & Plastic Surgery device
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Dec 2014
Decision
84d
Days
Class 2
Risk

K142777 is an FDA 510(k) clearance for the Weck Hem-o-lok Auto Endo5 Ligating Clip Applier. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 84 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K142777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2014
Decision Date December 19, 2014
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K142777.
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
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ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K142120 · AtriCure, Inc. · Aug 2014
ATRICLIP GILLINOV-COSGROVE LAA CLIP
K131107 · AtriCure, Inc. · May 2013