510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Stryker Laparoscopic Suction Irrigator

K934094510(k) TraditionalCleared Feb 18, 1994179-day reviewClass II21 CFR 876.1500Recalls 3

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

Stryker Corp. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Feb 18, 1994 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it. It has been recalled 3 times.

Decided
Feb 18, 1994
Review
179 days
Class
Class II
Product code
GCJ
Recalls
3
Predicates
0

37 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared2011: 2 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2006: 1 descendant cleared2019: 2 descendants cleared2017: 4 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2018: 3 descendants cleared2022: 4 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2026: 3 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2020: 2 descendants cleared1990200020102020
  1. This deviceK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994
  2. Descendant · cites it directly · 30 of its ownK992126 Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
  3. Descendant · 2 generations on · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
  4. 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
  5. Descendant · 4 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
  6. Descendant · 5 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12005: 12006: 12008: 12010: 22011: 22013: 12014: 12015: 22016: 22017: 42018: 32019: 22020: 22022: 42023: 12024: 22025: 12026: 3
1997high 4 (2017) · low 0 (1998)2026

Most influential descendants

Showing 5 of 37 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934094Stryker Laparoscopic Suction IrrigatorStryker Corp.1994—
+1K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp.1999—
+2K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…New Wave Surgical Corporation20062
+3K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC2008—
+4K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2015—
+5K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200510
200610
200810
201020
201120
201310
201410
201520
201620
201740
201830
201920
202020
202240
202310
202420
202510
202630
FIG. 1 — Lineage of K934094, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp.199930
K963765Stryker Strykeflow Electrocautery ProbesStryker Endoscopy19975

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 18, 2025Class IIZ-2170-2025Under Investigation by firmDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Sep 12, 2019Class IIZ-1509-2020OtherPotential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This…
Nov 17, 2017Class IIZ-0835-2018Under Investigation by firmRoutine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

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

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
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

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

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https://510kreport.com/device/K934094 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934094: Stryker Laparoscopic Suction Irrigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934094

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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