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FDA 510(k)

ONIK-COHEN ACCESS SET

K-Number: K930608 · 1993-07-09

ApplicantCook Urological, Inc.
Decision Date1993-07-09
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ONIK-COHEN ACCESS SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K930608. 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 ONIK-COHEN ACCESS SET?

ONIK-COHEN ACCESS SET is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Cook Urological, Inc.. The 510(k) number is K930608.

When did ONIK-COHEN ACCESS SET receive FDA 510(k) clearance?

ONIK-COHEN ACCESS SET received FDA 510(k) clearance on 1993-07-09, under 510(k) number K930608.

Who is the listed applicant for ONIK-COHEN ACCESS SET?

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

What is the FDA product code for ONIK-COHEN ACCESS SET?

The FDA product code for ONIK-COHEN ACCESS SET is KOD.

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Related Devices (Code: KOD)

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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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