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FDA 510(k)

HEM-O-LOK LIGATING CLIP

K-Number: K133202 · 2013-12-03

ApplicantTeleflex Medical
Decision Date2013-12-03
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEM-O-LOK LIGATING CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2013-12-03 under 510(k) number K133202. 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 CLIP?

HEM-O-LOK LIGATING CLIP is a medical device that received FDA 510(k) clearance on 2013-12-03. The listed applicant is Teleflex Medical. The 510(k) number is K133202.

When did HEM-O-LOK LIGATING CLIP receive FDA 510(k) clearance?

HEM-O-LOK LIGATING CLIP received FDA 510(k) clearance on 2013-12-03, under 510(k) number K133202.

Who is the listed applicant for HEM-O-LOK LIGATING CLIP?

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 CLIP?

The FDA product code for HEM-O-LOK LIGATING CLIP is FZP.

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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.

K261418Liquick X-treme, Liquick X-treme PlusK251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsK242495LMA Fastrach ETT SUK243553QuikClot Control+ Hemostatic DeviceK241784Arrow® Nitinol WireK233713Pilling Tracheostomy Tubes

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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.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

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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