# K962119: RE-New Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Microline Pentax, Inc.
- Decided: Aug 9, 1996 after 70 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932648 (1993). 1 ancestor in all.
31 later devices descend from it; 11 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932648: Quick Switch Laparoscopic Instruments, Microline Pentax, Inc. (1993) Summary page 1.

## Most influential descendants
- K970826: Selecta-Tip Laparoscopic Scissors (1997), 11 descendants of its own
- K980758: 3 MM Selec-Tip Laparoscopic Scissors (1998), 10 descendants of its own
- K014207: Reposable Instrument System, Models MF001-MF083 (2002), 8 descendants of its own
- K063485: Logic Laparoscopic Scissors (2006), 7 descendants of its own
- K974066: RE-New Forceps Laparoscopic Surgical Tips (1998), 6 descendants of its own

## Recalls of this device
- Nov 1, 2017 · Class II · Z-1741-2018: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
- 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 “Quick Switch” and “Re-New” are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

Source page: https://510kreport.com/device/K962119
Methodology: https://510kreport.com/methodology