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FDA 510(k)

TI CLIP APPLIER

K-Number: K034029 · 2004-03-05

ApplicantGyrx, LLC
Decision Date2004-03-05
Product CodeNJC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TI 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 2004-03-05 under 510(k) number K034029. The device is classified under product code NJC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TI CLIP APPLIER?

TI CLIP APPLIER is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Gyrx, LLC. The 510(k) number is K034029.

When did TI CLIP APPLIER receive FDA 510(k) clearance?

TI CLIP APPLIER received FDA 510(k) clearance on 2004-03-05, under 510(k) number K034029.

Who is the listed applicant for TI 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 TI CLIP APPLIER?

The FDA product code for TI CLIP APPLIER is NJC.

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.

K033161VISU-LOCK 5MM CLIP APPLIER

Related Devices (Code: NJC)

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.

K021745VASCLIPVmbc, LLC

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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