510(k) · Cleared

Cleared

Surgiquest Elastomeric Optical Trocar & Cannula

K063859510(k) TraditionalCleared Mar 14, 200776-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 Mar 14, 2007 as substantially equivalent to K903419 (United States Surgical, A Division of Tyco Healthc, 1990) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1990. 54 later devices descend from it.

Decided: Mar 14, 2007
Review: 76 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K903419 (1990). 2 ancestors in all. 54 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK903419 Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco Healthc · 1990
This deviceK063859 Surgiquest Elastomeric Optical Trocar & CannulaSurgiquest, Inc. · 2007
Descendant · cites it directly · 51 of its ownK083211 Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
Descendant · cites it directly · 36 of its ownK071571 Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007
Descendant · 2 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
Descendant · 3 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
Descendant · 4 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2007high 8 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 54 · See all

K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008 · cites it directly51descendants
K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007 · cites it directly36descendants
K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 2 generations on35descendants
K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 3 generations on27descendants
K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 4 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903419	Modified Surgiport Disposable Trocar and Sleeve	United States Surgical, A Division of Tyco Healthc	1990	—
0 (this device)	K063859	Surgiquest Elastomeric Optical Trocar & Cannula	Surgiquest, Inc.	2007	—
+1	K083211	Airseal Optical Trocar & Cannula System	Surgiquest, Inc.	2008	—
+1	K071571	Surgiquest Airseal Optical Trocar & Cannula System	Surgiquest, Inc.	2007	—
+2	K103692	Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator…	Surgiquest, Inc.	2011	—
+3	K143404	SurgiQuest AirSeal iFS System	Surgiquest, Inc.	2015	11
+4	K170784	Pneumoclear	W.O.M. World of Medicine GmbH	2017	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2010	1	0
2011	1	0
2012	3	0
2013	4	0
2014	1	0
2015	1	0
2017	2	0
2018	5	0
2019	5	0
2020	4	0
2021	1	0
2022	1	0
2023	3	0
2024	6	0
2025	6	0
2026	8	0

FIG. 1 — Lineage of K063859, 1990–2026Source: 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 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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K903419	Modified Surgiport Disposable Trocar and Sleeve Summary page 1 …(Trademark name to be determined) PREDICATE DEVICE SurgiportTM Blunt Tip Trocar U.S. Surgical Corp. (Norwalk, CT) K903419 EndoPath III T M Trocar System Ethicon Endo-Surgery, Inc. (Cincinnati, OH)…	United States Surgical, A Division of Tyco Healthc	1990	—
*	K032676	Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar Summary page 1 …K903419 EndoPath III T M Trocar System Ethicon Endo-Surgery, Inc. (Cincinnati, OH) K032676 DEVICE DESCRIPTION The subject is a surgical trocar and cannula composed of biosafe materials. The dev…	Ethicon Endo-Surgery, Inc.	2003	6

Also cleared against K903419: 5 other devices →

What descends from it? (54)

See all 54

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

Number	Device	Applicant	Decided	Descendants
K083211	Airseal Optical Trocar & Cannula System	Surgiquest, Inc.	2008	51
K071571	Surgiquest Airseal Optical Trocar & Cannula System	Surgiquest, Inc.	2007	36
K100180	Surgiquest Anchorport Sil Kit	Surgiquest, Inc.	2010	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K083211 (Surgiquest, Inc., 2008) has gone furthest, with 51 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. 2007, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063859 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063859: Surgiquest Elastomeric Optical Trocar & Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063859

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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