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FDA 510(k)

Endosee System

K-Number: K190639 · 2019-05-15

ApplicantCooperSurgical, Inc.
Decision Date2019-05-15
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endosee System is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2019-05-15 under approval number K190639. 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 System?

Endosee System is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K190639.

When was Endosee System approved by the FDA?

Endosee System received FDA 510(k) clearance on 2019-05-15, under approval number K190639.

What company makes Endosee System?

Endosee System is manufactured by CooperSurgical, Inc..

What is the FDA product code for Endosee System?

The FDA product code for Endosee System is HIH.

Other Devices by CooperSurgical, Inc.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula K170560SAGE Vitrification Kit and SAGE Vitrification Warming Kit K180429Advincula Delineator Uterine Manipulator K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K191291Wallace Dual Lumen Oocyte Recovery System

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Related Devices (Code: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.

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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