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FDA 510(k)

STERILE, ALL PURPOSE URETHRAL CATHETER

K-Number: K830444 · 1983-03-09

ApplicantAbco Dealers, Inc.
Decision Date1983-03-09
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE, ALL PURPOSE URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830444. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE, ALL PURPOSE URETHRAL CATHETER?

STERILE, ALL PURPOSE URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K830444.

When did STERILE, ALL PURPOSE URETHRAL CATHETER receive FDA 510(k) clearance?

STERILE, ALL PURPOSE URETHRAL CATHETER received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830444.

Who is the listed applicant for STERILE, ALL PURPOSE URETHRAL CATHETER?

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

What is the FDA product code for STERILE, ALL PURPOSE URETHRAL CATHETER?

The FDA product code for STERILE, ALL PURPOSE URETHRAL CATHETER is KOD.

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Other records listing Abco Dealers, Inc. as applicant

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Related Devices (Code: KOD)

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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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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