# K991719: Epistar/Epistar Cse Spinal/Epidural Anesthesia Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medimex Holfeld GmbH & Co.
- Decided: Aug 18, 1999 after 90 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may be combined with a spinal anesthetic. The MEDIMEX CSE epidural needle in the Epistar CSE kit I is intended for single epidural injections for epidural anesthesia, or for introduction of the MEDIMEX catheter in the CSE kit for continuous epidural anesthesia, for cathetcrization duration of up to 72 hours. The CSE epidural necdle is also intended to allow passage of a pencil point-spinal needle into the intrathecal space to provide anesthesia immediately before or after placement of the epidyral catheter. The MEDIMEX Epistar epidural kit containing the conventional epistar epidural needle, is intended only to provide epidural anesthesia by single epidural injection or by catheterization of the epidural space for up to 72 hours.

Source page: https://510kreport.com/device/K991719
Methodology: https://510kreport.com/methodology