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FDA 510(k)

COLPO CUP CVC-2000

K-Number: K974563 · 1998-03-02

ApplicantClinical Innovations, Inc.
Decision Date1998-03-02
Product CodeHDP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COLPO CUP CVC-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, Inc.. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K974563. The device is classified under product code HDP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLPO CUP CVC-2000?

COLPO CUP CVC-2000 is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Clinical Innovations, Inc.. The 510(k) number is K974563.

When did COLPO CUP CVC-2000 receive FDA 510(k) clearance?

COLPO CUP CVC-2000 received FDA 510(k) clearance on 1998-03-02, under 510(k) number K974563.

Who is the listed applicant for COLPO CUP CVC-2000?

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

What is the FDA product code for COLPO CUP CVC-2000?

The FDA product code for COLPO CUP CVC-2000 is HDP.

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Other records listing Clinical Innovations, Inc. as applicant

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.

K030691FETAL SPIRAL ELECTRODE, MODEL FSE07000K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MK974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERK973746PRE-FILLED SYRINGE FOR KOALA IUP

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Related Devices (Code: HDP)

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.

K974801SINGLE CHANNEL BALLOON CANNULAConkin Surgical Instruments , Ltd.K882054HYSTERO KITZinnanti Surgical Instruments, Inc.K820672HASSON BUEC-3Bivona Medical Technologies

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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