# K960148: Circon-Surgitek Classic Double Pigtail Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cabot Medical Corp.
- Decided: Mar 25, 1996 after 74 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K860267 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860267: Mardis Dangler Ureteral Stent Set, Van-Tec, Inc. (1986) Summary page 1.
- K930731: Slip-Coat Stents, Cook Urological, Inc. (1994) Summary page 1.
- K905289: Surgitek (R) Lubri-Flex (TM) Ureteral Stent, Medical Engineering Corp. (1991) Summary page 1.
- K946296: Quadra-Coil Ureteral Stent, Surgitek (1995) Summary page 1.

## Indications for use
The Surgitek Classic Double Pigtail Ureteral Stent is an indwelling device used to provide drainage from the kidney to the bladder and stenting of the ureter without external catheters. The stent may be placed using endoscopic, percutaneous or open procedures.

Source page: https://510kreport.com/device/K960148
Methodology: https://510kreport.com/methodology