510(k) Report

510(k) · Cleared

Cleared

Laparoscopic Irrigation Pump

K911493510(k) TraditionalCleared Apr 25, 199121-day reviewClass II21 CFR 876.1500

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

United States Endoscopy Group, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 25, 1991 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 25, 1991
Review
21 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared2004: 1 descendant cleared2007: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK911493 Laparoscopic Irrigation PumpUnited States Endoscopy Group, Inc. · 1991
  2. Descendant · cites it directly · 3 of its ownK961224 Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 1996
  3. Descendant · 2 generations on · 2 of its ownK033573 Linvatec 10K Irrigation SystemLinvatec Corp. · 2004
  4. Descendant · 2 generations on · 1 of its ownK063326 Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007
  5. Descendant · 3 generations on · 0 of its ownK182882 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable…Conmed Corporation · 2018

Most influential descendants

Showing 4 of 4 · See all
  • K961224Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 1996 · cites it directly3descendants
  • K033573Linvatec 10K Irrigation SystemLinvatec Corp. · 2004 · 2 generations on2descendants
  • K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007 · 2 generations on1descendant
  • K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911493Laparoscopic Irrigation PumpUnited States Endoscopy Group, Inc.1991—
+1K961224Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc.1996—
+2K033573Linvatec 10K Irrigation SystemLinvatec Corp.2004—
+2K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec2007—
+3K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200410
200710
201810
FIG. 1 — Lineage of K911493, 1991–2018Source: 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

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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? (4)

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

NumberDeviceApplicantDecidedDescendants
K961224Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc.19963

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, K961224 (Davol Inc., Sub. C. R. Bard, Inc., 1996) has gone furthest, with 3 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/K911493 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911493: Laparoscopic Irrigation Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911493

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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