# K955265: Cordis Sharp-Ended Stylet; Blunt-Ended Stylet; Cyst Puncture Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Dec 20, 1996 after 402 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- 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 K913636 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913636: Orbis-Sigma Valve System for Ventricular Shunting, Cordis Corp. (1991) Summary page 1.
- K914995: Cordis Straight Ventricular Catheter, Cordis Corp. (1992) Summary page 1.
- (no number) Elekta Blacklund Needle (Preamendments): named in the summary without a submission number
- (no number) Cordis Ventricular Catheter Stylet (Preamendments): named in the summary without a submission number

## Indications for use
The Cordis Cyst Puncture Catheter Kit is used to puncture and drain thick-walled or mobile intracranial cysts.

Source page: https://510kreport.com/device/K955265
Methodology: https://510kreport.com/methodology