510(k) · Cleared

Recalled · Class II · 2022

Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010

K961492510(k) TraditionalCleared May 15, 199627-day reviewClass II21 CFR 876.1500Recalls 2

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

Davol Inc., Sub. C. R. Bard, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on May 15, 1996 after a 27-day review. The FDA summary names its predicate without a number. 35 later devices descend from it. It has been recalled 2 times.

Decided: May 15, 1996
Review: 27 days
Class: Class II
Product code: GCJ
Recalls: 2
Predicates: 0

35 later devices descend from it, 4 citing it directly.

This deviceK961492 Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010Davol Inc., Sub. C. R. Bard, Inc. · 1996
Descendant · cites it directly · 30 of its ownK992126 Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
Descendant · 2 generations on · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
Descendant · 3 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
Descendant · 4 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
Descendant · 5 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

1998high 4 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 35 · See all

K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999 · cites it directly30descendants
K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · 2 generations on23descendants
K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 3 generations on16descendants
K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 4 generations on8descendants
K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 5 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K961492	Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010	Davol Inc., Sub. C. R. Bard, Inc.	1996	—
+1	K992126	Circon Surgiflex Wave Tsunami Suction-Irrigation System	Circon Corp.	1999	—
+2	K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…	New Wave Surgical Corporation	2006	2
+3	K080613	Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045	Minimally Invasive Devices, LLC	2008	—
+4	K151117	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2015	—
+5	K160172	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2006	1	0
2008	1	0
2010	1	0
2011	1	0
2014	1	0
2015	2	0
2016	2	0
2017	4	0
2018	3	0
2019	1	0
2020	2	0
2021	1	0
2022	4	0
2023	1	0
2024	2	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K961492, 1996–2026Source: 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 GCJ? 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 GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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? (2)

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
*	—	Endo-Flo Irrigation System Named without a submission number			—
*	—	StrykeFlow Disposable Suction Irrigator Named without a submission number			—

What descends from it? (35)

See all 35

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K992126	Circon Surgiflex Wave Tsunami Suction-Irrigation System	Circon Corp.	1999	30
K202303	CORE E3 Suction/irrigator	Conmed Corporation	2021	1
K252957	Pneumo Dissector Hook	Ab Medica Sas	2026	0
K981940	Multapump Disposable Pump Head and Accessories	Dexide, Inc.	1998	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 7, 2022	Class II	Z-1304-2022	Under Investigation by firm	The product is not able to provide irrigation.
Jun 7, 2022	Class II	Z-1305-2022	Under Investigation by firm	The product is not able to provide irrigation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K992126 (Circon Corp., 1999) has gone furthest, with 30 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The Hydro-Surg Irrigator is designed to be used in conjunction with a laparoscopic probe handle and tip to provide controlled powered irrigation/aspiration during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.

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/K961492 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961492: Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961492

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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