Cleared Special

Endosee System

K190639 · CooperSurgical, Inc. · Obstetrics & Gynecology
May 2019
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K190639 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 May 15, 2019, 63 days after receiving the submission on March 13, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K190639 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2019
Decision Date May 15, 2019
Days to Decision 63 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

Similar Devices — HIH Hysteroscope (and Accessories)

All 168
InnovexView (GC146-17, GC150-20, GC155-23)
K254251 · Shanghai AnQing Medical Instrument Co., Ltd. · Feb 2026
ARMI? 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)
K252793 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Dec 2025
SPY Cystoscope/Hysteroscope
K252012 · Stryker Endoscopy · Jul 2025
RZ Resectoscope System
K243382 · Rz Medizintechnik GmbH · Jun 2025
SeleneView? Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
K240978 · MacroLux Medical Technology Co., Ltd. · Aug 2024
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Aug 2024