Cleared Traditional

Hem-o-lok? PurplePlus? Large Polymer Ligating Clips

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

About This 510(k) Submission

K251054 is an FDA 510(k) clearance for the Hem-o-lok? PurplePlus? Large Polymer Ligating Clips, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on July 3, 2025, 90 days after receiving the submission on April 4, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K251054 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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