# K201884: ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

- Pathway: 510(k) (Traditional)
- Applicant: Microline Surgical, Inc.
- Decided: Oct 21, 2020 after 105 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: 2 generations back to K932648 (1993). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962119: RE-New Laparoscopic Instruments, Microline Pentax, Inc. (1996) Summary page 4.

## Most influential descendants
- K252535: Inno-Switch™ Laparoscopic Instruments (2026), 0 descendants of its own
- 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) (2024), 0 descendants of its own

## Indications for use
The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

Source page: https://510kreport.com/device/K201884
Methodology: https://510kreport.com/methodology