# K150127: Laparoscopic Handles with peek Insulation

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Feb 4, 2015 after 15 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K973259 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973259: K&W 2-Piece Take-Apart Instruments (Various), Medical Creative Technologies, Inc. (1997) Summary page 4.

## Most influential descendants
- K173272: Ergonomic Handle (2018), 0 descendants of its own

## Indications for use
The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.

Source page: https://510kreport.com/device/K150127
Methodology: https://510kreport.com/methodology
