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FDA 510(k)

COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE

K-Number: K003958 · 2001-02-06

ApplicantCoalescent Surgical
Decision Date2001-02-06
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Coalescent Surgical. It received FDA 510(k) clearance on 2001-02-06 under 510(k) number K003958. 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 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE?

COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE is a medical device that received FDA 510(k) clearance on 2001-02-06. The listed applicant is Coalescent Surgical. The 510(k) number is K003958.

When did COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE receive FDA 510(k) clearance?

COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE received FDA 510(k) clearance on 2001-02-06, under 510(k) number K003958.

Who is the listed applicant for COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE?

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

What is the FDA product code for COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE?

The FDA product code for COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE is FZP.

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Other records listing Coalescent Surgical 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.

K040821COALESCENT SURGICAL U-CLIP AND ACCESSORIESK031623MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIESK024366COALESCENT SURGICAL U-CLIP AND ACCESSORIESK023125COALESCENT U-CLIP- AND ACCESSORIESK021407COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIESK013664COALESCENT SURGICAL U-CLIP

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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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