Cleared Traditional

Hysteroscope System

K181545 · Shanghai AnQing Medical Instrument Co., Ltd. · Obstetrics & Gynecology
May 2019
Decision
332d
Days
Class 2
Risk

About This 510(k) Submission

K181545 is an FDA 510(k) clearance for the Hysteroscope System, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 10, 2019, 332 days after receiving the submission on June 12, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K181545 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2018
Decision Date May 10, 2019
Days to Decision 332 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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