# K981611: Snap-N-Peel Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Circon Corp.
- Decided: Jul 30, 1998 after 85 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: 1 generation back to K961904 (1996). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961904: AQ Hydrophilic Dilators, Cook Urological, Inc. (1996) Summary page 1.
- K971165: Introducer Sheath and Dilator, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K051593: Uropass Ureteral Access Sheath, Model 61224 (2005), 5 descendants of its own
- K120160: Rocamed Rocaus Platinum (2012), 2 descendants of its own
- K140441: BI-Flex Ureteral Access Sheath (2014), 1 descendant of its own
- K123170: Vari-Pass Variable Length Access Sheath (2013), 1 descendant of its own
- K182403: Peel-Away Introducer (2019), 0 descendants of its own

## Indications for use
CIRCON SURGITEK’s Snap-N-Peel™ Introducers are 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/K981611
Methodology: https://510kreport.com/methodology