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FDA 510(k)

COALESCENT SURGICAL U-CLIP

K-Number: K013664 · 2002-01-24

ApplicantCoalescent Surgical
Decision Date2002-01-24
Product CodeNCA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COALESCENT SURGICAL U-CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Coalescent Surgical. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K013664. The device is classified under product code NCA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COALESCENT SURGICAL U-CLIP?

COALESCENT SURGICAL U-CLIP is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Coalescent Surgical. The 510(k) number is K013664.

When did COALESCENT SURGICAL U-CLIP receive FDA 510(k) clearance?

COALESCENT SURGICAL U-CLIP received FDA 510(k) clearance on 2002-01-24, under 510(k) number K013664.

Who is the listed applicant for COALESCENT SURGICAL U-CLIP?

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 SURGICAL U-CLIP?

The FDA product code for COALESCENT SURGICAL U-CLIP is NCA.

Related Clinical Trials

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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 ACCESSORIESK012317COALESCENT SURGICAL U-CLIP

View all 9 devices →

Related Devices (Code: NCA)

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.

K011589CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), MBypass , Ltd.K003446SYMMETRY AORTIC CLIP SYSTEMSt. Jude Medical Cardiovascular Group, Inc.

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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