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FDA 510(k)

HYSTERO KIT

K-Number: K882054 · 1988-09-29

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1988-09-29
Product CodeHDP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTERO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1988-09-29 under 510(k) number K882054. 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 HYSTERO KIT?

HYSTERO KIT is a medical device that received FDA 510(k) clearance on 1988-09-29. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K882054.

When did HYSTERO KIT receive FDA 510(k) clearance?

HYSTERO KIT received FDA 510(k) clearance on 1988-09-29, under 510(k) number K882054.

Who is the listed applicant for HYSTERO KIT?

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

What is the FDA product code for HYSTERO KIT?

The FDA product code for HYSTERO KIT is HDP.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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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.K974563COLPO CUP CVC-2000Clinical Innovations, 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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