# K982984: Accushear Laparoscopic Surgical Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Microline Pentax, Inc.
- Decided: Oct 21, 1998 after 56 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: 4 generations back to K932648 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K980758: 3 MM Selec-Tip Laparoscopic Scissors, Microline Pentax, Inc. (1998) Summary page 1.

## Indications for use
Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

Source page: https://510kreport.com/device/K982984
Methodology: https://510kreport.com/methodology