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FDA 510(k)

Hem-o-lok® Ligating Clips

K-Number: K232970 · 2024-01-12

ApplicantTeleflex Medical
Decision Date2024-01-12
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hem-o-lok® 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 2024-01-12 under 510(k) number K232970. 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® Ligating Clips?

Hem-o-lok® Ligating Clips is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Teleflex Medical. The 510(k) number is K232970.

When did Hem-o-lok® Ligating Clips receive FDA 510(k) clearance?

Hem-o-lok® Ligating Clips received FDA 510(k) clearance on 2024-01-12, under 510(k) number K232970.

Who is the listed applicant for Hem-o-lok® 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® Ligating Clips?

The FDA product code for Hem-o-lok® 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, vascularK251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsK242495LMA Fastrach ETT SUK243553QuikClot Control+ Hemostatic Device

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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.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter Int

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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