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FDA 510(k)

COOK TISSUE MORCELLATOR

K-Number: K925851 · 1993-05-21

ApplicantCook Urological, Inc.
Decision Date1993-05-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOK TISSUE MORCELLATOR 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 1993-05-21 under 510(k) number K925851. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK TISSUE MORCELLATOR?

COOK TISSUE MORCELLATOR is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Cook Urological, Inc.. The 510(k) number is K925851.

When did COOK TISSUE MORCELLATOR receive FDA 510(k) clearance?

COOK TISSUE MORCELLATOR received FDA 510(k) clearance on 1993-05-21, under 510(k) number K925851.

Who is the listed applicant for COOK TISSUE MORCELLATOR?

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 COOK TISSUE MORCELLATOR?

The FDA product code for COOK TISSUE MORCELLATOR is GEI.

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Other records listing Cook Urological, Inc. as applicant

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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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