# K200925: Clarus Peel-Away Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: Mar 18, 2021 after 345 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015, Medtronic PS Medical (1999) Summary page 4.

## Indications for use
The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.

Source page: https://510kreport.com/device/K200925
Methodology: https://510kreport.com/methodology