# K061135: Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap
- Decided: Jul 11, 2006 after 78 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883607 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022513: Medcomp Vascu-Sheath Introducer Set, Medcomp (2002) Summary page 1.
- K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015, Medtronic PS Medical (1999) Summary page 1.

## Indications for use
THE MINOP® DISPOSABLE INTRODUCER IS INDICATED TO OBTAIN AND MAINTAIN A TEMPORARY PATHWAY INTO THE VENTRICULAR SYSTEM OF THE BRAIN.

Source page: https://510kreport.com/device/K061135
Methodology: https://510kreport.com/methodology