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FDA 510(k)

SINGLE CHANNEL BALLOON CANNULA

K-Number: K974801 · 1998-07-09

ApplicantConkin Surgical Instruments , Ltd.
Decision Date1998-07-09
Product CodeHDP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SINGLE CHANNEL BALLOON CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Conkin Surgical Instruments , Ltd.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K974801. 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 SINGLE CHANNEL BALLOON CANNULA?

SINGLE CHANNEL BALLOON CANNULA is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Conkin Surgical Instruments , Ltd.. The 510(k) number is K974801.

When did SINGLE CHANNEL BALLOON CANNULA receive FDA 510(k) clearance?

SINGLE CHANNEL BALLOON CANNULA received FDA 510(k) clearance on 1998-07-09, under 510(k) number K974801.

Who is the listed applicant for SINGLE CHANNEL BALLOON CANNULA?

The FDA 510(k) record lists Conkin Surgical Instruments , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE CHANNEL BALLOON CANNULA?

The FDA product code for SINGLE CHANNEL BALLOON CANNULA is HDP.

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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.

K974563COLPO CUP CVC-2000Clinical Innovations, Inc.K882054HYSTERO KITZinnanti Surgical Instruments, Inc.K820672HASSON BUEC-3Bivona Medical Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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