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FDA 510(k)

AXIOM ATRAUM WOUND DRAINS

K-Number: K883887 · 1989-02-17

ApplicantAxiom, Inc.
Decision Date1989-02-17
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXIOM ATRAUM WOUND DRAINS is the device name listed in this FDA 510(k) record. The listed applicant is Axiom, Inc.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K883887. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM ATRAUM WOUND DRAINS?

AXIOM ATRAUM WOUND DRAINS is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Axiom, Inc.. The 510(k) number is K883887.

When did AXIOM ATRAUM WOUND DRAINS receive FDA 510(k) clearance?

AXIOM ATRAUM WOUND DRAINS received FDA 510(k) clearance on 1989-02-17, under 510(k) number K883887.

Who is the listed applicant for AXIOM ATRAUM WOUND DRAINS?

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

What is the FDA product code for AXIOM ATRAUM WOUND DRAINS?

The FDA product code for AXIOM ATRAUM WOUND DRAINS is GBS.

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 Axiom, 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.

K842443AXIOM STABLE II TRIGLYCERIDES TESTK842442AXIOM STABLE II URIC ACID TESTK842441AXIOM STABLE II CHOLESTEROL TEST

Related Devices (Code: GBS)

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.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.K872460AN3000 MAHONEY DRAINH.W. Andersen Products, 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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