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R-MED Motorized Laparoscopic Handle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K945637

by R-Med, Inc.

Identifiers

510(k) Number
K945637 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 R-MED Motorized Laparoscopic Handle is a surgical instrument designed for use in laparoscopic procedures. It provides motorized assistance to facilitate the manipulation and control of laparoscopic tools during surgery.

This device is intended for use in laparoscopic surgeries and is supplied by R-Med, Inc. It is regulated under FDA 510(k) clearance with reference number K945637. The device is associated with the product code GCJ and falls under the advisory committee categories of Gastroenterology and Urology. The regulatory decision was made on December 7, 1994, with a substantially equivalent determination.

Frequently asked questions

What is the R-MED Motorized Laparoscopic Handle used for?

This surgical instrument is designed for use in laparoscopic procedures, where it provides motorized assistance to facilitate the manipulation and control of laparoscopic tools during surgery.

How is the device supplied?

The device is supplied by R-Med, Inc., located at 3465 Navarre Ave., Box 167636, Oregon, OH 43616, United States.

What is the regulatory status of this device?

The device is regulated under FDA 510(k) clearance with reference number K945637. It received a substantially equivalent determination on December 7, 1994, under product code GCJ.

Is this a single-use or reusable device?

The provided data does not specify whether the device is single-use or reusable. This information would typically be found in the manufacturer's labeling or instructions for use.

What sizes or models are available?

The device data identifies only one specific model: the R-MED Motorized Laparoscopic Handle associated with K945637. No additional sizes or variants are listed in the regulatory record.

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: R-MED MOTORIZED LAPAROSCOPIC HANDLE - Innolitics, R-Med Products, R-med Motorized Laparoscopic Handle 510(k) K945637 - FDA.report, R-Med, Inc. - Safe & Effective Medical Products

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
R-Med, Inc.

Sources (1)

  • FDA 510(k) K945637 24 fields · synced Sep 25, 2026