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Hysteroscope System (HIH)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181545

by Shanghai Anqing Medical Instrument Co., Ltd

Identifiers

510(k) Number
K181545 FDA 510(k)
FDA Product Code
HIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1690 FDA 510(k)
Regulation Number
884.1690 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Hysteroscope (And Accessories) as classified under 21 CFR § 884.1690, designed for visual inspection of the cervical canal and uterine cavity. It enables diagnostic and therapeutic procedures within the female reproductive tract, including assessment of abnormalities, tissue sampling, and minimally invasive interventions.

The system is supplied as a reusable medical device and is intended for use in clinical settings such as obstetrics and gynecology. It is regulated under FDA 510(k) clearance (K181545) and falls under Class II classification. The device includes multiple referenced components (e.g., FEI numbers and registration codes) and is manufactured by Shanghai Anqing Medical Instrument Co., Ltd., adhering to regulatory standards for hysteroscopic procedures.

Frequently asked questions

Is this hysteroscope system designed for single-use or reusable procedures, and how does that affect its maintenance requirements?

This hysteroscope system is explicitly labeled as a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and sterilization. As a reusable device, it requires adherence to strict infection control protocols, including cleaning between patients and sterilization after each use to ensure safety and functionality. The manufacturer, Shanghai Anqing Medical Instrument Co., Ltd., likely provides guidelines for maintenance and reprocessing to comply with clinical and regulatory standards.

What clinical specialties or procedures is this device primarily intended to support, and how does it assist in those areas?

This device is classified under Obstetrics/Gynecology and is designed for visual inspection of the cervical canal and uterine cavity. It enables both diagnostic and therapeutic procedures, such as assessing abnormalities, tissue sampling, and minimally invasive interventions within the female reproductive tract. Clinicians in these specialties may use it for procedures like hysteroscopy, polyp removal, or fibroid evaluation.

Does this device come with multiple components, and if so, how are those parts referenced or identified?

Yes, this Hysteroscope System includes multiple referenced components, each identified by unique FEI numbers (e.g., 3015139943, 3011459664) and registration numbers (e.g., 2954783, 3015139943). These identifiers are used for regulatory tracking and compliance, ensuring each part is properly accounted for in clinical and administrative settings. The system’s accessories are part of the broader FDA 510(k)-cleared classification under 21 CFR § 884.1690.

What regulatory pathway was followed for this device’s clearance, and what does that mean for its use in clinical settings?

This device received FDA 510(k) clearance (K181545) under the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms it meets FDA safety and effectiveness standards for use in diagnostic and therapeutic hysteroscopic procedures within obstetrics and gynecology. Clinicians can rely on this approval for its intended clinical applications as outlined in the device’s labeling.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hysteroscope System 510 (k) FDA Premarket Notification K181545 Shanghai ..., K181545 - Hysteroscope (And Accessories) FDA 510 (k) APPLICATION FOR ..., Hysteroscope System (K181545) — FDA 510 (k) | Innolitics, PDF May 10, 2019 Shanghai AnQing Medical Instrument CO., Ltd. Lina Fei ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai Anqing Medical Instrument Co., Ltd
FDA Applicant
Shanghai AnQing Medical Instrument Co., Ltd.

Sources (1)

  • FDA 510(k) K181545 24 fields · synced Oct 6, 2026