510(k) · Cleared

Cleared

Circon-Surgitek Classic Double Pigtail Ureteral Stent

K960148510(k) TraditionalCleared Mar 25, 199674-day reviewClass II21 CFR 876.4620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cabot Medical Corp. · FAD Stent, Ureteral

Cleared on Mar 25, 1996 as substantially equivalent to K860267 (Van-Tec, Inc., 1986) and 3 other predicates after a 74-day review. Its family tree reaches back 1 generation to 1986.

Decided: Mar 25, 1996
Review: 74 days
Class: Class II
Product code: FAD
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K860267 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK860267 Mardis Dangler Ureteral Stent SetVan-Tec, Inc. · 1986 · Recalled
This deviceK960148 Circon-Surgitek Classic Double Pigtail Ureteral StentCabot Medical Corp. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860267	Mardis Dangler Ureteral Stent Set	Van-Tec, Inc.	1986	1
0 (this device)	K960148	Circon-Surgitek Classic Double Pigtail Ureteral Stent	Cabot Medical Corp.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	1	0
1995	1	0

FIG. 1 — Lineage of K960148, 1986–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FAD device

#1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K860267	Mardis Dangler Ureteral Stent Set Summary page 1 …quivalent by the US FDA. The Circon-Surgitek Classic Double Pigtail Ureteral Stent is substantially equivalent to the following devices; 1) the Microvasive Mardis Stent [K860267), 2) the Cook Double Pigtail Stent [K930731]; 3) the Circon-Surgitek Lubri-Flex [K905289] and 4) the Circon-Surgitek Quadra-Coil™…	Van-Tec, Inc.	1986	1
*	K930731	Slip-Coat Stents Summary page 1 …Classic Double Pigtail Ureteral Stent is substantially equivalent to the following devices; 1) the Microvasive Mardis Stent [K860267), 2) the Cook Double Pigtail Stent [K930731]; 3) the Circon-Surgitek Lubri-Flex [K905289] and 4) the Circon-Surgitek Quadra-Coil™ [K946296]. fi iveness : Cj…	Cook Urological, Inc.	1994	—
*	K905289	Surgitek (R) Lubri-Flex (TM) Ureteral Stent Summary page 1 …stantially equivalent to the following devices; 1) the Microvasive Mardis Stent [K860267), 2) the Cook Double Pigtail Stent [K930731]; 3) the Circon-Surgitek Lubri-Flex [K905289] and 4) the Circon-Surgitek Quadra-Coil™ [K946296]. fi iveness : Cj - itek Double Pigtail Ureteral Stent Device…	Medical Engineering Corp.	1991	—
*	K946296	Quadra-Coil Ureteral Stent Summary page 1 …the Microvasive Mardis Stent [K860267), 2) the Cook Double Pigtail Stent [K930731]; 3) the Circon-Surgitek Lubri-Flex [K905289] and 4) the Circon-Surgitek Quadra-Coil™ [K946296]. fi iveness : Cj - itek Double Pigtail Ureteral Stent Device Description and Intended Use of the Marketed Devic…	Surgitek	1995	—
†	K913928	Surgitek (R) 4.5FR Lubri-Flex (TM) Ureteral Stent	Surgitek Medical Engineering Corp.	1991	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 4 ancestors has a recall of any class.

How does its category compare?

All FAD devices

FAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAD

4in 2025

2007high 9 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAD

186in 2025

2007high 266 (2017) · low 143 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FAD

4in 2025

2007high 22 (2008) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAD

634in 2025

2007high 691 (2023) · low 43 (2007)2025

MAUDE reports naming product code FAD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	43
2008	1	—	22	76
2009	0	—	2	123
2010	1	—	1	78
2011	0	—	0	95
2012	0	—	0	131
2013	0	—	0	82
2014	1	—	0	78
2015	0	—	0	130
2016	4	143	4	182
2017	8	266	0	265
2018	9	258	0	277
2019	5	263	6	261
2020	1	—	2	352
2021	2	—	1	531
2022	5	143	9	559
2023	0	—	0	691
2024	1	—	0	603
2025	4	186	4	634
2026	1	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960148 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960148: Circon-Surgitek Classic Double Pigtail Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960148

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026