510(k) · Cleared

Recalled · 2011

Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003

K090902510(k) TraditionalCleared Jul 22, 2009112-day reviewClass II21 CFR 876.1500Recalls 1

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

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

Cleared on Jul 22, 2009 as substantially equivalent to K082619 (Covidien Lp, Formerly Registered AS United States, 2008) and 1 other predicate after a 112-day review. Its family tree reaches back 5 generations to 1994. 46 later devices descend from it. It has been recalled once.

Decided: Jul 22, 2009
Review: 112 days
Class: Class II
Product code: GCJ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 5 generations to K940232 (1994). 24 ancestors in all, the oldest K883018 (1988). 46 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
4 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
3 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
2 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
1 generation backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
This deviceK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009
Descendant · cites it directly · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
Descendant · 2 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
Descendant · 2 generations on · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
Descendant · 2 generations on · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
Descendant · 3 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2011high 8 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 46 · See all

K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · cites it directly43descendants
K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc. · 2012 · 2 generations on42descendants
K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · 2 generations on39descendants
K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · 2 generations on22descendants
K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K940232	Innerdyne Step Trocar Expandable Port, S.T.E.P.	Innerdyne Medical, Inc.	1994	—
−4	K961940	Innerdyne Step Trocar Expandable Port, Onestep	Innerdyne, Inc.	1996	1
−3	K012539	Verastep	United States Surgical, A Division of Tyco Healthc	2001	—
−2	K072814	Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…	Covidien	2008	—
−1	K082619	Sils Port, Models SILSPT5, SILSPT12	Covidien Lp, Formerly Registered AS United States	2008	—
0 (this device)	K090902	Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…	Transenterix, Inc.	2009	—
+1	K112208	Intutive Surgical DA Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	2011	12
+2	K120215	Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…	Intuitive Surgical, Inc.	2012	3
+2	K122532	DA Vinci Single-Site Instruments and Accessories	Intuitive Surgical, Inc.	2013	6
+2	K131962	DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2014	—
+3	K173906	da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2018	9

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1991	1	0
1992	2	0
1993	1	0
1994	3	0
1995	4	0
1998	1	0
2001	2	0
2003	1	0
2006	1	0
2007	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	1	0
2013	2	0
2014	4	0
2015	1	0
2016	2	0
2017	2	0
2018	3	0
2019	2	0
2020	3	0
2021	3	0
2022	1	0
2023	3	0
2024	6	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K090902, 1994–2026Source: 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

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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
*	K082619	Sils Port, Models SILSPT5, SILSPT12 Summary page 1 …ndoscope and accessories Classification: Class II21 CFR 876.1500 Product Code: GCJ 3. Predicate Device: Covidien, SILS Port - K082619 Endopath III Bladeless Trocar - K032676 4. Description: The SPIDERTM is a single port, single incision device to facilitate…	Covidien Lp, Formerly Registered AS United States	2008	—
*	K032676	Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar Summary page 1 …: Class II21 CFR 876.1500 Product Code: GCJ 3. Predicate Device: Covidien, SILS Port - K082619 Endopath III Bladeless Trocar - K032676 4. Description: The SPIDERTM is a single port, single incision device to facilitate multi-instrument access during laparoscopic…	Ethicon Endo-Surgery, Inc.	2003	6

Also cleared against K082619: 3 other devices →

What descends from it? (46)

See all 46

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

Number	Device	Applicant	Decided	Descendants
K112208	Intutive Surgical DA Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	2011	43
K160797	FMX314 Surgical Platform	Fortimedix Surgical B.V.	2016	0
K102839	Spider Standard and Advanced	Transenterix, Inc.	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 25, 2011	Not classified	Z-1909-2011	Other	Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
3 of the 24 ancestors have a recall of any class.
Of its descendants, K112208 (Intuitive Surgical, Inc., 2011) has gone furthest, with 43 descendants of its own.
3 other devices also cite its predicate K082619.

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

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 SPIDER TM (Single Port Instrument Delivery Extended Reach) is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090902 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090902: Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090902

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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