# K123170: Vari-Pass Variable Length Access Sheath

- Pathway: 510(k) (Special)
- Applicant: Olympus Surgical Technologies America
- Decided: Feb 4, 2013 after 118 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961904 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981611: Snap-N-Peel Introducers, Circon Corp. (1998) Summary page 1.
- K051593: Uropass Ureteral Access Sheath, Model 61224, Acmi Corporation (2005) Summary page 1.

## Most influential descendants
- K182403: Peel-Away Introducer (2019), 0 descendants of its own

## Indications for use
Gyrus ACMI1 Vari-PassTm Adjustable Length Access Sheath is intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g.; nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.

Source page: https://510kreport.com/device/K123170
Methodology: https://510kreport.com/methodology