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FDA 510(k)

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

K-Number: K251054 · 2025-07-03

ApplicantTeleflex Medical
Decision Date2025-07-03
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2025-07-03 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K251054.

When did Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips receive FDA 510(k) clearance?

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

Who is the listed applicant for Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06364865AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery StudyCOMPLETED

Other records listing Teleflex Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureK260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™PMA P180025Device, hemostasis, vascularK242495LMA Fastrach ETT SUK243553QuikClot Control+ Hemostatic DeviceK241784Arrow® Nitinol Wire

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Related Devices (Code: FZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter IntK221495SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd.

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.

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