# K971146: Laparette

- Pathway: 510(k) (Traditional)
- Applicant: Rd Chus, Inc.
- Decided: Aug 25, 1997 after 150 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912492 (1991). 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)
- K921696: Cutting and Coagulation Devices and Accessories, American Cyanamid Co. (1992) Summary page 1.
- K912492: Evacuation/Irrigation/Elecrosurgical Device, ETHICON, Inc. (1991) Summary page 1.

## Most influential descendants
- K022979: Laparette, Model Lap J L S H N (2002), 0 descendants of its own

## Indications for use
The LAPARETTE is an electrosurgical instrument with integral suction and irrigation capability It is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high frequency electrical current, to irrigate tissue and cavities, as well as to suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.

Source page: https://510kreport.com/device/K971146
Methodology: https://510kreport.com/methodology