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FDA 510(k)

DETECT CYTOLOGY BRUSH II

K-Number: K960469 · 1996-03-14

ApplicantCook Urological, Inc.
Decision Date1996-03-14
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DETECT CYTOLOGY BRUSH 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 1996-03-14 under 510(k) number K960469. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETECT CYTOLOGY BRUSH II?

DETECT CYTOLOGY BRUSH II is a medical device that received FDA 510(k) clearance on 1996-03-14. The listed applicant is Cook Urological, Inc.. The 510(k) number is K960469.

When did DETECT CYTOLOGY BRUSH II receive FDA 510(k) clearance?

DETECT CYTOLOGY BRUSH II received FDA 510(k) clearance on 1996-03-14, under 510(k) number K960469.

Who is the listed applicant for DETECT CYTOLOGY BRUSH 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 DETECT CYTOLOGY BRUSH II?

The FDA product code for DETECT CYTOLOGY BRUSH II is HHT.

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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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