# K974066: RE-New Forceps Laparoscopic Surgical Tips

- Pathway: 510(k) (Traditional)
- Applicant: Microline Pentax, Inc.
- Decided: Jan 22, 1998 after 87 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.
6 later devices descend from it; 2 cite it directly.
0 of 9 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 1.

## Most influential descendants
- K981389: Disposable RE-New Forceps (1998), 4 descendants of its own
- K071976: Vectec Disposable Trocars and Laparoscopic Accessories (2007), 3 descendants of its own
- K101937: Hybrid Trocar System (2010), 1 descendant of its own
- K171523: Monopolar Single Use Laparoscopic Instrument (2017), 0 descendants of its own
- K153126: da Vinci Xi Hasson Cone (2015), 0 descendants of its own

## Recalls of this device
- Jul 13, 2017 · Class II · Z-0507-2018: The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there

## Indications for use
The “Re-New Forceps” Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

Source page: https://510kreport.com/device/K974066
Methodology: https://510kreport.com/methodology