FDA 510(k)

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

K-번호: K170660 · 2017-07-13

결정일2017-07-13

제품 코드HIH

자문 위원회OB

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K170660.

When did Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula receive FDA 510(k) clearance?

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

Who is the listed applicant for Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula?

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 Hysteroscope with Disposable Diagnostic (Dx) Cannula?

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

CooperSurgical, Inc.를 신청인으로 등재한 기타 기록

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)K243799Fetal Pillow K250438CooperSurgical Milex® Pessaries K223064ALLY II Uterine Positioning System™ (UPS)K201086Advincula Delineator Uterine Manipulator K200038Endosee System

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