510(k) · Cleared

Cleared

Urosprobe System, Model 1000

K960387510(k) TraditionalCleared Apr 1, 199666-day reviewClass II21 CFR 878.4350

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

Uros Corp. · GEH Unit, Cryosurgical, Accessories

Cleared on Apr 1, 1996 after a 66-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 95 later devices descend from it.

Decided: Apr 1, 1996
Review: 66 days
Class: Class II
Product code: GEH
Recalls: None
Predicates: 0

95 later devices descend from it, 1 citing it directly.

This deviceK960387 Urosprobe System, Model 1000Uros Corp. · 1996
Descendant · cites it directly · 94 of its ownK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
Descendant · 2 generations on · 93 of its ownK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
Descendant · 3 generations on · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
Descendant · 4 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
Descendant · 5 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

1997high 10 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 95 · See all

K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997 · cites it directly94descendants
K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998 · 2 generations on93descendants
K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · 3 generations on92descendants
K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 4 generations on90descendants
K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 5 generations on42descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960387	Urosprobe System, Model 1000	Uros Corp.	1996	—
+1	K973686	Endocare Cryocare Cryosurgical System	Endocare, Inc.	1997	—
+2	K980110	Endocre Cryocare Cryosurgical System	Endocare, Inc.	1998	—
+3	K011722	Atricure Bipolar Coagulation System	AtriCure, Inc.	2001	—
+4	K020919	Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1	AtriCure, Inc.	2002	—
+5	K040690	Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…	Cryocath Technologies, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2001	1	0
2002	1	0
2003	1	0
2004	3	0
2005	2	0
2006	10	0
2007	4	0
2008	10	0
2009	3	0
2010	3	0
2011	4	0
2012	7	0
2013	2	0
2014	5	0
2015	1	0
2016	1	0
2017	1	0
2018	5	0
2019	8	0
2020	2	0
2021	2	0
2022	3	0
2023	2	0
2024	6	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K960387, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (95)

See all 95

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K973686	Endocare Cryocare Cryosurgical System	Endocare, Inc.	1997	94

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?

Of its descendants, K973686 (Endocare, Inc., 1997) has gone furthest, with 94 descendants of its own.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007high 206 (2021) · low 42 (2014)2026

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

Recalls per year · GEH

2in 2023

2007high 37 (2020) · low 0 (2011)2026

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

Adverse event reports per year · GEH

171in 2025

2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, 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	6	71	3	23
2008	1	—	2	29
2009	4	121	13	21
2010	4	86	4	173
2011	7	91	0	61
2012	4	96	3	91
2013	4	76	0	91
2014	6	42	2	57
2015	11	72	0	97
2016	15	60	0	143
2017	12	83	0	216
2018	6	42	1	208
2019	6	115	1	455
2020	8	113	37	277
2021	6	206	0	213
2022	6	56	0	230
2023	8	136	2	164
2024	9	85	0	141
2025	10	77	0	171
2026	8	148	2	—

https://510kreport.com/device/K960387 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960387: Urosprobe System, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960387

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026