# K912443: Candela Introducer Sheath System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Laser Corp.
- Decided: Aug 16, 1991 after 74 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955717: Endoscope Introducer Kit (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K912443
Methodology: https://510kreport.com/methodology