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FDA 510(k)

COALESCENT U-CLIP- AND ACCESSORIES

K-Number: K023125 · 2002-12-18

ApplicantCoalescent Surgical
Decision Date2002-12-18
Product CodeNJU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COALESCENT U-CLIP- AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Coalescent Surgical. It received FDA 510(k) clearance on 2002-12-18 under 510(k) number K023125. The device is classified under product code NJU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COALESCENT U-CLIP- AND ACCESSORIES?

COALESCENT U-CLIP- AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Coalescent Surgical. The 510(k) number is K023125.

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

COALESCENT U-CLIP- AND ACCESSORIES received FDA 510(k) clearance on 2002-12-18, under 510(k) number K023125.

Who is the listed applicant for COALESCENT U-CLIP- AND ACCESSORIES?

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- AND ACCESSORIES?

The FDA product code for COALESCENT U-CLIP- AND ACCESSORIES is NJU.

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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 ACCESSORIESK021407COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIESK013664COALESCENT SURGICAL U-CLIPK012317COALESCENT SURGICAL U-CLIP

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Related Devices (Code: NJU)

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.

K023372NON-BIOABSORBABLE STAPLEOnux Medical, 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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