# K252535: Inno-Switch™ Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Surgical Corporation
- Decided: Aug 25, 2026 after 378 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K213127: ReNew Disposable Scissor Tips, Microline Surgical, Inc. (2022) Summary page 5.

## Indications for use
Inno-Switch™ Laparoscopic Instruments are indicated for cutting, grasping, dissecting, and coagulating tissue in endoscopic and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K252535
Methodology: https://510kreport.com/methodology