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Lagis Endoscopic Instruments Disposable Grasper

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K141902

by Lagis Enterprises Co, Ltd.

Identifiers

510(k) Number
K141902 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 Lagis Endoscopic Instruments Disposable Grasper is a single-use endoscopic accessory classified as a grasper under the Gastroenterology and Urology device categories. It is designed for use in minimally invasive procedures to grasp, hold, or manipulate tissue or instruments within the body during endoscopic examinations or interventions.

This device is supplied sterile and intended for single-use only, adhering to FDA 510(k) clearance under the Traditional pathway as Substantially Equivalent (SESE). It is manufactured by Lagis Enterprises Co., Ltd., and falls under the product code GCJ, with regulatory compliance also meeting EU MDR standards. Storage and handling must follow sterile medical device protocols to ensure integrity before use.

Frequently asked questions

What types of medical procedures is this disposable grasper designed to assist with?

This grasper is specifically designed for use in minimally invasive endoscopic procedures within the gastroenterology and urology specialties. It is intended to grasp, hold, or manipulate tissue or instruments during examinations or interventions, such as biopsies, polyp removals, or other manipulations inside the body.

Is this device reusable, or is it meant for single-use only?

The Lagis Endoscopic Instruments Disposable Grasper is explicitly labeled for single-use only. This classification ensures patient safety and sterility, as it is supplied sterile and must not be reused after a single procedure.

How should this device be stored to maintain its sterility before use?

Since this grasper is supplied sterile, it must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging until immediately before use and avoiding exposure to contamination or environmental hazards that could compromise its sterility.

What regulatory pathways has this device undergone, and what does that mean for its use?

This device has received FDA 510(k) clearance under the Traditional pathway, determined to be *Substantially Equivalent (SESE)* to a legally marketed predicate. It also complies with EU MDR (Medical Device Regulation) standards. These clearances confirm that it meets regulatory requirements for safety and performance in its intended endoscopic applications.

Are there different sizes or models available for this grasper?

The provided specifications do not list specific sizes or models for the Lagis Endoscopic Instruments Disposable Grasper. For precise details on available variations, such as jaw width or length, you would need to consult the manufacturer’s product catalog or technical documentation.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lagis Enterprises Co, Ltd.

Sources (2)

  • FDA 510(k) K141902 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026