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FDA 510(k)

AXIOM LIG-A-BOOTS

K-Number: K820161 · 1982-03-15

ApplicantAxiom Medical, Inc.
Decision Date1982-03-15
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXIOM LIG-A-BOOTS 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 1982-03-15 under 510(k) number K820161. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM LIG-A-BOOTS?

AXIOM LIG-A-BOOTS is a medical device that received FDA 510(k) clearance on 1982-03-15. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K820161.

When did AXIOM LIG-A-BOOTS receive FDA 510(k) clearance?

AXIOM LIG-A-BOOTS received FDA 510(k) clearance on 1982-03-15, under 510(k) number K820161.

Who is the listed applicant for AXIOM LIG-A-BOOTS?

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 AXIOM LIG-A-BOOTS?

The FDA product code for AXIOM LIG-A-BOOTS is KDC.

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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 CATHETERK965146FLAT CLOSED WOUND DRAIN WITH TROCARK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINS

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Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, 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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