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FDA 510(k)

DuraFuse Clip and Applier System

K-Number: K213813 · 2022-07-22

ApplicantNeuramedica, Inc.
Decision Date2022-07-22
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DuraFuse Clip and Applier System is the device name listed in this FDA 510(k) record. The listed applicant is Neuramedica, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K213813. 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 DuraFuse Clip and Applier System?

DuraFuse Clip and Applier System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Neuramedica, Inc.. The 510(k) number is K213813.

When did DuraFuse Clip and Applier System receive FDA 510(k) clearance?

DuraFuse Clip and Applier System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K213813.

Who is the listed applicant for DuraFuse Clip and Applier System?

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

What is the FDA product code for DuraFuse Clip and Applier System?

The FDA product code for DuraFuse Clip and Applier System is FZP.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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