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FDA 510(k)

VISU-LOCK 5MM CLIP APPLIER

K-Number: K033161 · 2003-12-18

ApplicantGyrx, LLC
Decision Date2003-12-18
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISU-LOCK 5MM CLIP APPLIER is the device name listed in this FDA 510(k) record. The listed applicant is Gyrx, LLC. It received FDA 510(k) clearance on 2003-12-18 under 510(k) number K033161. 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 VISU-LOCK 5MM CLIP APPLIER?

VISU-LOCK 5MM CLIP APPLIER is a medical device that received FDA 510(k) clearance on 2003-12-18. The listed applicant is Gyrx, LLC. The 510(k) number is K033161.

When did VISU-LOCK 5MM CLIP APPLIER receive FDA 510(k) clearance?

VISU-LOCK 5MM CLIP APPLIER received FDA 510(k) clearance on 2003-12-18, under 510(k) number K033161.

Who is the listed applicant for VISU-LOCK 5MM CLIP APPLIER?

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

What is the FDA product code for VISU-LOCK 5MM CLIP APPLIER?

The FDA product code for VISU-LOCK 5MM CLIP APPLIER 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.

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Other records listing Gyrx, LLC 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.

K034029TI CLIP APPLIER

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

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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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