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FDA 510(k)

INSEMI-CATH II

K-Number: K954398 · 1995-12-19

ApplicantCook Urological, Inc.
Decision Date1995-12-19
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSEMI-CATH II 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 1995-12-19 under 510(k) number K954398. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSEMI-CATH II?

INSEMI-CATH II is a medical device that received FDA 510(k) clearance on 1995-12-19. The listed applicant is Cook Urological, Inc.. The 510(k) number is K954398.

When did INSEMI-CATH II receive FDA 510(k) clearance?

INSEMI-CATH II received FDA 510(k) clearance on 1995-12-19, under 510(k) number K954398.

Who is the listed applicant for INSEMI-CATH II?

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 INSEMI-CATH II?

The FDA product code for INSEMI-CATH II is MFD.

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Related Devices (Code: MFD)

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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