Cleared Traditional

Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

K170660 · CooperSurgical, Inc. · Obstetrics & Gynecology
Jul 2017
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K170660 is an FDA 510(k) clearance for the Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on July 13, 2017, 132 days after receiving the submission on March 3, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K170660 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2017
Decision Date July 13, 2017
Days to Decision 132 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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