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FDA 510(k)

DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)

K-Number: K910254 · 1991-04-18

ApplicantCooperSurgical, Inc.
Decision Date1991-04-18
Product CodeHHE
Advisory CommitteeOB
DecisionUnknown

Device Summary

DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1991-04-18 under 510(k) number K910254. The device is classified under product code HHE. It was reviewed by the OB advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)?

DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K910254.

When did DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) receive FDA 510(k) clearance?

DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) received FDA 510(k) clearance on 1991-04-18, under 510(k) number K910254.

Who is the listed applicant for DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)?

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

What is the FDA product code for DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)?

The FDA product code for DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) is HHE.

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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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