FDA 510(k)

Hem-o-lok PurplePlus Large Polymer Ligating Clips

K-Number: K251054 · 2025-07-03

Decision Date2025-07-03

Product CodeFZP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Hem-o-lok PurplePlus Large Polymer Ligating Clips is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2025-07-03 under approval number K251054. 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 Hem-o-lok PurplePlus Large Polymer Ligating Clips?

Hem-o-lok PurplePlus Large Polymer Ligating Clips is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Teleflex Medical. The 510(k) number is K251054.

When was Hem-o-lok PurplePlus Large Polymer Ligating Clips approved by the FDA?

Hem-o-lok PurplePlus Large Polymer Ligating Clips received FDA 510(k) clearance on 2025-07-03, under approval number K251054.

What company makes Hem-o-lok PurplePlus Large Polymer Ligating Clips?

Hem-o-lok PurplePlus Large Polymer Ligating Clips is manufactured by Teleflex Medical.

What is the FDA product code for Hem-o-lok PurplePlus Large Polymer Ligating Clips?

The FDA product code for Hem-o-lok PurplePlus Large Polymer Ligating Clips is FZP.

Related Clinical Trials

NCT06364865 AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study COMPLETED NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING

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Related Devices (Code: FZP)

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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.