ReNew XR Handpiece, 25cm, with Reference Markings (3943M) +5 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K234147

Identifiers

510(k) Number: K234147 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: ReNew XR Handpiece, 25cm, with Reference Markings (3943M) FDA 510(k)EUDAMED
ReNew XR Handpiece, 34cm, with Reference Markings (3941M) FDA 510(k)EUDAMED
ReNew XR Handpiece, 42cm, with Reference Markings (3942M) FDA 510(k)EUDAMED
ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M) FDA 510(k)EUDAMED
ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M) FDA 510(k)EUDAMED
ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The ReNew XR Handpiece is a reusable laparoscopic instrument designed for cutting, grasping, dissecting, and coagulation of tissue during endoscopic and laparoscopic procedures. It features reference markings for precise tissue length measurement, aiding in surgical accuracy during minimally invasive operations.

The handpiece is supplied in reusable configurations with varying lengths (25cm, 34cm, 42cm) and includes ratcheted variants for enhanced control. Compatible with disposable or reusable scissor, grasper, or dissector tips, it is intended for use in sterile surgical environments. Authorised under FDA 510K and MDR, these devices adhere to regulatory standards for laparoscopic instruments.

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: ReNew XR Laparoscopic Handpiece™ with Reference Markings, ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR ..., ReNew XR Laparoscopic Handpiece™ | Microline Surgical

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K234147	Class II	Active

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Manufacturer

Manufacturer: Microline Surgical, Inc.

Sources (2)

FDA 510(k) K234147 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026