# K234147: ReNew XR Handpiece, 25cm, with Reference Markings  (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings  (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)

- Pathway: 510(k) (Traditional)
- Applicant: Microline Surgical, Inc.
- Decided: Apr 23, 2024 after 116 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932648 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201884: ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm, Microline Surgical, Inc. (2020) Summary page 5.

## Indications for use
The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures. The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K234147
Methodology: https://510kreport.com/methodology