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FDA 510(k)

TUBING, AXIOM SILICONE PENROSE

K-Number: K781749 · 1978-12-04

ApplicantAxiom Medical, Inc.
Decision Date1978-12-04
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TUBING, AXIOM SILICONE PENROSE 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 1978-12-04 under 510(k) number K781749. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBING, AXIOM SILICONE PENROSE?

TUBING, AXIOM SILICONE PENROSE is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K781749.

When did TUBING, AXIOM SILICONE PENROSE receive FDA 510(k) clearance?

TUBING, AXIOM SILICONE PENROSE received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781749.

Who is the listed applicant for TUBING, AXIOM SILICONE PENROSE?

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 TUBING, AXIOM SILICONE PENROSE?

The FDA product code for TUBING, AXIOM SILICONE PENROSE is KDH.

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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: KDH)

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.

K983624GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.K981286SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSArmm, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K962850TUM-E-VACEthox Corp.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, 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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