510(k) Report

510(k) · Cleared

Cleared

Airseal Optical Trocar & Cannula System

K083211510(k) TraditionalCleared Dec 15, 200845-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 Dec 15, 2008 as substantially equivalent to K903419 (United States Surgical, A Division of Tyco Healthc, 1990) and 4 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1990. 51 later devices descend from it.

Decided
Dec 15, 2008
Review
45 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K903419 (1990). 5 ancestors in all. 51 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor1991: 1 other ancestor2011: 1 descendant cleared2012: 3 descendants cleared2013: 4 descendants cleared2015: 1 descendant cleared2018: 5 descendants cleared2014: 1 descendant cleared2019: 5 descendants cleared2017: 2 descendants cleared2020: 4 descendants cleared2024: 6 descendants cleared2025: 6 descendants cleared2022: 1 descendant cleared2026: 8 descendants cleared2021: 1 descendant cleared2023: 3 descendants clearedK903419 · Modified Surgiport Disposable Trocar and Sleeve · United States Surgical, A Division of Tyco Healthc · 1990K063859 · Surgiquest Elastomeric Optical Trocar & Cannula · Surgiquest, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 10 descendants5 generations forward: 7 descendants6 generations forward: 9 descendants7 generations forward: 5 descendants K063859 · Surgiquest Elastomeric Optical Trocar & Cannula · Surgiquest, Inc. · 2007K903419 · Modified Surgiport Disposable Trocar and Sleeve · United States Surgical, A Division of Tyco Healthc · 19900+5
  1. Root · 2 generations backK903419 Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc · 1990
  2. 1 generation backK063859 Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007
  3. This deviceK083211 Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
  4. Descendant · cites it directly · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
  5. Descendant · 2 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
  6. Descendant · 3 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
  7. Descendant · 4 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
  8. Descendant · cites it directly · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32013: 42014: 12015: 12017: 22018: 52019: 52020: 42021: 12022: 12023: 32024: 62025: 62026: 8
2011high 8 (2026) · low 0 (2016)2026

Most influential descendants

Showing 5 of 51 · 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
  • K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · cites it directly14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K903419Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc1990—
−1K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc.2007—
0 (this device)K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc.2008—
+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—
+1K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201340
201410
201510
201720
201850
201950
202040
202110
202210
202330
202460
202560
202680
FIG. 1 — Lineage of K083211, 1990–2026Source: 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), 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. #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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K903419Modified Surgiport Disposable Trocar and Sleeve
Summary page 1
…(Trademark name to be determined) PREDICATE SurgiportTm Blunt Tip Trocar DEVICE(S) U.S. Surgical Corp. (Norwalk, CT) K903419 EndoPath Ill Trocar System Ethicon Endo-Surgery, Inc. (Cincinnati, OH)…
United States Surgical, A Division of Tyco Healthc1990—
*K032676Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar
Summary page 1
…, CT) K903419 EndoPath Ill Trocar System Ethicon Endo-Surgery, Inc. (Cincinnati, OH) K032676 Elastomneric Optical Trocar & Cannula SurgiQuest, Inc. (Orange, CT)…
Ethicon Endo-Surgery, Inc.20036
*K063859Surgiquest Elastomeric Optical Trocar & Cannula
Summary page 1
…ati, OH) K032676 Elastomneric Optical Trocar & Cannula SurgiQuest, Inc. (Orange, CT) K063 859 LapEvac Filtration Device for the Pneumnoperitoneumn Buffalo Filter (Buffalo, NY)…
Surgiquest, Inc.2007—
*K052797Lapevac, Filtration Device for the Periotoneum
Summary page 1
…K063 859 LapEvac Filtration Device for the Pneumnoperitoneumn Buffalo Filter (Buffalo, NY) K052797 Sun Medical Smoke / Fluid Evacuation System Sun Medical Inc. (Arlington, TX)…
Medtek Devices, Inc.2006—
*K911154Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200
Summary page 1
…K052797 Sun Medical Smoke / Fluid Evacuation System Sun Medical Inc. (Arlington, TX) K911154 DEVICE DESCRIPTION The subject is a surgical trocar and cannula, composed of medical grade materials. The…
Sun Medical, Inc.1991—

Also cleared against K903419: 5 other devices →

What descends from it? (51)

See all 51

2 later devices cite 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
K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG201214

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?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K103692 (Surgiquest, Inc., 2011) has gone furthest, with 35 descendants of its own.
  • 5 other devices also cite its predicate K903419.

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. 2008, 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 summary.

Also cleared against K903419

5 other devices cite the same predicate.

  • K100180Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010
  • K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007
  • K063859Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007
  • K992288Auto Suture* Soft Thoracoport** Obturator and SleeveTyco Intl. (Us), Inc. · 1999
  • K974763Deroyal Industries Disposable Surgical Trocar/CannulaDeroyal Industries, Inc. · 1998

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

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https://510kreport.com/device/K083211 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083211: Airseal Optical Trocar & Cannula System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083211

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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