# K955717: Endoscope Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Cable America, Inc.
- Decided: Apr 18, 1996 after 122 days
- Product code: FDE (Laparoscopy Kit)
- 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 K912443 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912443: Candela Introducer Sheath System, Candela Laser Corp. (1991) Summary page 1.

## Indications for use
The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.

Source page: https://510kreport.com/device/K955717
Methodology: https://510kreport.com/methodology