Cleared Special

Endosee System

K200038 · CooperSurgical, Inc. · Obstetrics & Gynecology
Feb 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K200038 is an FDA 510(k) clearance for the Endosee System, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on February 5, 2020, 28 days after receiving the submission on January 8, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K200038 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2020
Decision Date February 05, 2020
Days to Decision 28 days
Submission Type Special
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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