510(k) Report

510(k) · Cleared

Cleared

Surgiquest Airseal Optical Trocar and Cannula System

K092504510(k) TraditionalCleared Nov 5, 200983-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

Surgiquest, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 5, 2009 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 36 later devices descend from it.

Decided
Nov 5, 2009
Review
83 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 1 descendant cleared2012: 2 descendants cleared2013: 3 descendants cleared2015: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2017: 2 descendants cleared2020: 3 descendants cleared2025: 6 descendants cleared2019: 2 descendants cleared2021: 1 descendant cleared2023: 2 descendants cleared2024: 4 descendants cleared2026: 7 descendants cleared20052010201520202025
  1. This deviceK092504 Surgiquest Airseal Optical Trocar and Cannula SystemSurgiquest, Inc. · 2009
  2. Descendant · cites it directly · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
  3. Descendant · 2 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
  4. Descendant · 3 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
  5. Descendant · 4 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
  6. Descendant · 5 generations on · 11 of its ownK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22013: 32014: 12015: 12017: 22018: 12019: 22020: 32021: 12023: 22024: 42025: 62026: 7
2011high 7 (2026) · low 0 (2016)2026

Most influential descendants

Showing 5 of 36 · See all
  • K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · cites it directly35descendants
  • K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 2 generations on27descendants
  • K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 3 generations on17descendants
  • K201361PneumoclearW.O.M. World of Medicine GmbH · 2020 · 4 generations on14descendants
  • K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc. · 2024 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092504Surgiquest Airseal Optical Trocar and Cannula SystemSurgiquest, Inc.2009—
+1K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.2011—
+2K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.201511
+3K170784PneumoclearW.O.M. World of Medicine GmbH20171
+4K201361PneumoclearW.O.M. World of Medicine GmbH2020—
+5K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with…Intuitive Surgical, Inc.20246

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201330
201410
201510
201720
201810
201920
202030
202110
202320
202440
202560
202670
FIG. 1 — Lineage of K092504, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135

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, K103692 (Surgiquest, Inc., 2011) has gone furthest, with 35 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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The SurgiQuest AirSealTM Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions.

Indications for use as stated in the FDA 510(k) statement.

More from Surgiquest, Inc.

9 FDA decisions under this applicant name. See the company

  • K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 201511 recalls
  • K132169Surgiquest Airseal IfsSurgiquest, Inc. · 2013
  • K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2012
  • K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011
  • K100180Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K092504 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092504: Surgiquest Airseal Optical Trocar and Cannula System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092504

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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