Cleared Traditional

K251054 - Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251054 · Teleflex Medical · General & Plastic Surgery device
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Jul 2025
Decision
90d
Days
Class 2
Risk

K251054 is an FDA 510(k) clearance for the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on July 3, 2025 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflex Medical devices

Submission Details

510(k) Number K251054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2025
Decision Date July 03, 2025
Days to Decision 90 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
24d faster than avg
Panel avg: 114d · This submission: 90d
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 175
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K251054.
InnoClip Clip Applier
K253781 · Taiwan Surgical Corporation · Dec 2025
InnoClip Disposable Clip Applier
K253903 · Taiwan Surgical Corporation · Dec 2025
Disposable Polymer Ligation Clips
K250643 · Hangzhou Kangji Medical Instrument Co., Ltd. · Nov 2025
GEM ZIPCLIP
K242541 · Synovis Micro Companies Alliance A Subsidiary of Baxter Int · Jan 2025
SOLID CLIP™ Single Use Clip Applier
K221495 · Medscope Biotech Co., Ltd. · Jul 2024
Hem-o-lok® Ligating Clips
K232970 · Teleflex Medical · Jan 2024