# K213127: ReNew Disposable Scissor Tips

- Pathway: 510(k) (Traditional)
- Applicant: Microline Surgical, Inc.
- Decided: Mar 2, 2022 after 156 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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 5.

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

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0663-2025: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.

## Indications for use
The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K213127
Methodology: https://510kreport.com/methodology