510(k) · Cleared

Cleared

Circon Surgiflex Wave Tsunami Suction-Irrigation System

K992126510(k) TraditionalCleared Aug 3, 199941-day reviewClass II21 CFR 880.6740

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

Circon Corp. · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Cleared on Aug 3, 1999 as substantially equivalent to K932626 (Cabot Medical Corp., 1994) and 2 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1994. 30 later devices descend from it.

Decided: Aug 3, 1999
Review: 41 days
Class: Class II
Product code: GCX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K934094 (1994). 3 ancestors in all. 30 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994 · Recalled
This deviceK992126 Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
Descendant · cites it directly · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
Descendant · 2 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
Descendant · 3 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
Descendant · 4 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
Descendant · 5 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2006high 4 (2017) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all

K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · cites it directly23descendants
K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 2 generations on16descendants
K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 3 generations on8descendants
K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 4 generations on7descendants
K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934094	Stryker Laparoscopic Suction Irrigator	Stryker Corp.	1994	3
0 (this device)	K992126	Circon Surgiflex Wave Tsunami Suction-Irrigation System	Circon Corp.	1999	—
+1	K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…	New Wave Surgical Corporation	2006	2
+2	K080613	Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045	Minimally Invasive Devices, LLC	2008	—
+3	K151117	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2015	—
+4	K160172	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2016	—
+5	K170103	Laparoscope Lens Shield Device (LENS)	Medeon Biodesign, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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
2022	4	0
2023	1	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K992126, 1994–2026Source: 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 GCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K932626	Cabot Medical Surgiflex (R) Suction-Irrigation Prob Summary page 1 …n System is substantially equivalent to Cabot Medical Corporation’s Surgiflex® Suction-Irrigation Probes that were cleared by FDA for marketing on 06/08/94 under 510(k) #K932626, Davol’s Hydro-Surg® Laparoscopic Irrigator that was cleared by FDA for marketing on 05/15/96 under 510(k) #K961492; and Stryker’…	Cabot Medical Corp.	1994	—
*	K961492	Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010 Summary page 1 …leared by FDA for marketing on 06/08/94 under 510(k) #K932626, Davol’s Hydro-Surg® Laparoscopic Irrigator that was cleared by FDA for marketing on 05/15/96 under 510(k) #K961492; and Stryker’s Laparoscopic Suction Irrigator that was cleared by FDA for marketing on 02/18/94 under 510(k) #K934094. (A modific…	Davol Inc., Sub. C. R. Bard, Inc.	1996	2
*	K934094	Stryker Laparoscopic Suction Irrigator Summary page 1 …ared by FDA for marketing on 05/15/96 under 510(k) #K961492; and Stryker’s Laparoscopic Suction Irrigator that was cleared by FDA for marketing on 02/18/94 under 510(k) #K934094. (A modification of Stryker’s Laparoscopic Suction Irrigator was subsequently cleared for marketing on 11/29/95 under 510(k) #K95…	Stryker Corp.	1994	3

Also cleared against K932626: 1 other device →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…	New Wave Surgical Corporation	2006	23
K110451	Endowrist One Suction/Irrigator	Intuitive Surgical, Inc.	2011	5

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?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K062779 (New Wave Surgical Corporation, 2006) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K932626.

How does its category compare?

All GCX devices

GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCX

FDA has decided no GCX device since 2007.

Median 510(k) review, days · GCX

Too few GCX 510(k)s in any year since 2007 to give a median.

Recalls per year · GCX

1in 2024

2007high 3 (2023) · low 0 (2007)2026

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

Adverse event reports per year · GCX

274in 2025

2007high 274 (2025) · low 24 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	24
2008	—	0	44
2009	—	0	40
2010	—	0	51
2011	—	0	67
2012	—	0	242
2013	—	1	47
2014	—	0	32
2015	—	0	52
2016	—	0	99
2017	—	1	45
2018	—	0	50
2019	—	0	65
2020	—	0	65
2021	—	0	65
2022	—	0	72
2023	—	3	59
2024	—	1	65
2025	—	0	274
2026	—	3	—

What is it indicated for?

Circon Corporation’s Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon’s Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for 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/K992126 · printed Nov 3, 2026

Cite this page

510(k) Report. “K992126: Circon Surgiflex Wave Tsunami Suction-Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K992126

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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