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FDA 510(k)

FLAT CLOSED WOUND DRAIN WITH TROCAR

K-Number: K965146 · 1997-03-10

ApplicantAxiom Medical, Inc.
Decision Date1997-03-10
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLAT CLOSED WOUND DRAIN WITH TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K965146. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLAT CLOSED WOUND DRAIN WITH TROCAR?

FLAT CLOSED WOUND DRAIN WITH TROCAR is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K965146.

When did FLAT CLOSED WOUND DRAIN WITH TROCAR receive FDA 510(k) clearance?

FLAT CLOSED WOUND DRAIN WITH TROCAR received FDA 510(k) clearance on 1997-03-10, under 510(k) number K965146.

Who is the listed applicant for FLAT CLOSED WOUND DRAIN WITH TROCAR?

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

What is the FDA product code for FLAT CLOSED WOUND DRAIN WITH TROCAR?

The FDA product code for FLAT CLOSED WOUND DRAIN WITH TROCAR is GBX.

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Other records listing Axiom 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.

K993592AXIOM MULTIPURPOSE WOUND DRAINK971851INTERPLEURAL ANESTHESIA CATHETERK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINSK904218SUCTION SYSTEM

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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