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FDA 510(k)

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

K-Number: K170660 · 2017-07-13

ApplicantCooperSurgical, Inc.
Decision Date2017-07-13
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2017-07-13 under approval number K170660. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is a medical device that received FDA 510(k) clearance on 2017-07-13. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K170660.

When was Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula approved by the FDA?

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula received FDA 510(k) clearance on 2017-07-13, under approval number K170660.

What company makes Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is manufactured by CooperSurgical, Inc..

What is the FDA product code for Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

The FDA product code for Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula is HIH.

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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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