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FDA 510(k)

Endosee System

K-Number: K200038 · 2020-02-05

ApplicantCooperSurgical, Inc.
Decision Date2020-02-05
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endosee System is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K200038. 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 2020-02-05. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K200038.

When did Endosee System receive FDA 510(k) clearance?

Endosee System received FDA 510(k) clearance on 2020-02-05, under 510(k) number K200038.

Who is the listed applicant for Endosee System?

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

What is the FDA product code for Endosee System?

The FDA product code for Endosee System is HIH.

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Related Devices (Code: HIH)

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K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

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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