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FDA 510(k)

NON-BIOABSORBABLE STAPLE

K-Number: K023372 · 2002-12-27

ApplicantOnux Medical, Inc.
Decision Date2002-12-27
Product CodeNJU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-BIOABSORBABLE STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Onux Medical, Inc.. It received FDA 510(k) clearance on 2002-12-27 under 510(k) number K023372. 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 NON-BIOABSORBABLE STAPLE?

NON-BIOABSORBABLE STAPLE is a medical device that received FDA 510(k) clearance on 2002-12-27. The listed applicant is Onux Medical, Inc.. The 510(k) number is K023372.

When did NON-BIOABSORBABLE STAPLE receive FDA 510(k) clearance?

NON-BIOABSORBABLE STAPLE received FDA 510(k) clearance on 2002-12-27, under 510(k) number K023372.

Who is the listed applicant for NON-BIOABSORBABLE STAPLE?

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

What is the FDA product code for NON-BIOABSORBABLE STAPLE?

The FDA product code for NON-BIOABSORBABLE STAPLE is NJU.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Onux Medical, Inc. 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.

K022777MANUAL TOUCHE SYSTEMK014286SALUTE, MODEL 3022K010620ENDOSCOPIC STAPLE REMOVAL INSTRUMENTK003522SALUTE

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.

K023125COALESCENT U-CLIP- AND ACCESSORIESCoalescent Surgical

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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