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Medical Shaver System (Morcellator) YSB-IIIA

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K251923

by Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

Identifiers

510(k) Number
K251923 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medical Shaver System (Morcellator) YSB-IIIA is a surgical device classified as a morcellator, designed for the fragmentation of tissue during minimally invasive procedures. It operates via a shaving mechanism to reduce tissue into smaller pieces, facilitating easier removal through small incisions, particularly in urological and gastrointestinal applications.

This device is supplied as a reusable system and is intended for use in sterile operating environments. It is approved under FDA 510K, MDD, and MDR regulations, with a product code of GCJ. The YSB-IIIA is regulated through the Gastroenterology and Urology advisory committees and is manufactured by Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

Frequently asked questions

What types of surgical procedures is this Medical Shaver System (Morcellator) primarily used for?

This device is designed for minimally invasive procedures in urological and gastrointestinal applications, where it fragments tissue into smaller pieces via a shaving mechanism. This allows for easier removal through small incisions, reducing the need for larger surgical openings.

Is the Medical Shaver System (Morcellator) YSB-IIIA meant for single-use or reusable applications?

The YSB-IIIA is explicitly supplied as a reusable system, meaning it is intended for use in sterile operating environments and can be cleaned, sterilized, and reused for multiple procedures. This design aligns with its classification as a surgical tool requiring maintenance and reprocessing.

How is the regulatory approval status of this device determined, and which committees oversee its classification?

The YSB-IIIA was granted substantial equivalence under the FDA’s 510(k) pathway, meaning it is deemed comparable to a legally marketed predicate device. Its regulatory oversight falls under the Gastroenterology and Urology (GU) advisory committees, which evaluate submissions under product code GCJ for devices in these specialties.

What does the manufacturer’s address and contact information indicate about the device’s origin and support?

The device is manufactured by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. at their facility in Hangzhou, China (address: #9 Xinda Rd., Suoqian, Xiaoshan, 311201). For inquiries, the contact person listed is Yayan Ding, though this information is primarily for administrative or technical support purposes rather than clinical use.

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: Medical Praxisbedarf

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

Sources (2)

  • FDA 510(k) K251923 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026