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FDA 510(k)

BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING

K-Number: K974295 · 1998-02-10

ApplicantByron Medical
Decision Date1998-02-10
Product CodeKGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K974295. The device is classified under product code KGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING?

BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Byron Medical. The 510(k) number is K974295.

When did BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING receive FDA 510(k) clearance?

BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974295.

Who is the listed applicant for BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING?

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

What is the FDA product code for BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING?

The FDA product code for BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING is KGZ.

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.

Other records listing Byron Medical 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.

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Related Devices (Code: KGZ)

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.

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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