510(k) · Cleared

Cleared

Sils Port, Models SILSPT5, SILSPT12

K082619510(k) TraditionalCleared Nov 7, 200859-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

Covidien Lp, Formerly Registered AS United States · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 7, 2008 as substantially equivalent to K981941 (Dexide, Inc., 1998) and 5 other predicates after a 59-day review. Its family tree reaches back 4 generations to 1994. 58 later devices descend from it.

Decided: Nov 7, 2008
Review: 59 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K940232 (1994). 23 ancestors in all, the oldest K883018 (1988). 58 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
3 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
2 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
1 generation backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
This deviceK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
Descendant · cites it directly · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
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

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2009high 8 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 58 · See all

K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · cites it directly46descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K940232	Innerdyne Step Trocar Expandable Port, S.T.E.P.	Innerdyne Medical, Inc.	1994	—
−3	K961940	Innerdyne Step Trocar Expandable Port, Onestep	Innerdyne, Inc.	1996	1
−2	K012539	Verastep	United States Surgical, A Division of Tyco Healthc	2001	—
−1	K072814	Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…	Covidien	2008	—
0 (this device)	K082619	Sils Port, Models SILSPT5, SILSPT12	Covidien Lp, Formerly Registered AS United States	2008	—
+1	K090902	Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…	Transenterix, Inc.	2009	1
+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	—

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
2009	2	0
2010	1	0
2011	4	0
2012	2	0
2013	2	0
2014	5	0
2015	2	0
2016	3	0
2017	3	0
2018	3	0
2019	2	0
2020	3	0
2021	3	0
2022	2	0
2023	3	0
2024	7	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K082619, 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K981941	Multaport Cannula Reducer and Accessories Summary page 1 …Surgical Trocar CLASSIFICATION NAME: Endoscope and/or accessories PREDICATE DEVICE(S): K981941: DexideTm Multaport Cannula Reducer and Accessories…	Dexide, Inc.	1998	—
*	K012539	Verastep Summary page 1 …K981941: DexideTm Multaport Cannula Reducer and Accessories K012539: Versa StepTm Reposable System K954 108: Modified VersaportT m Trocar…	United States Surgical, A Division of Tyco Healthc	2001	—
*	K954108	Modified Versaport Summary page 1 …and Accessories K012539: Versa StepTm Reposable System K954 108: Modified VersaportT m Trocar K0728 14: Convenience Kit for "Single-Incision…	United States Surgical, A Division of Tyco Healthc	1995	—
*	K072814	Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic… Summary page 1 …539: Versa StepTm Reposable System K954 108: Modified VersaportT m Trocar K0728 14: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced…	Covidien	2008	—
*	K945457	Trocar ( Accesory) Summary page 1 …Laparoscopic Surgery and other advanced laparoscopic procedures." K945457: Auto SutureTm Modified Grip K073 170: R-Port II Laparoscopic Access Device DEV…	United States Surgical, A Division of Tyco Healthc	1994	—
*	K073170	R-Port II Laparoscopic Access Device Summary page 1 …laparoscopic procedures." K945457: Auto SutureTm Modified Grip K073 170: R-Port II Laparoscopic Access Device DEVICE DESCRIPTION: Three laparoscopic trocars and an insuffla…	Advanced Surgical Concepts	2007	—

Also cleared against K981941: 3 other devices →

What descends from it? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K090902	Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003	Transenterix, Inc.	2009	46
K112208	Intutive Surgical DA Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	2011	43
K093372	Sils Port Model SILSPT15	Covidien Lp, Formerly Registered AS Tyco Healthcar	2009	9
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?

The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
3 of the 23 ancestors have a recall of any class.
Of its descendants, K090902 (Transenterix, Inc., 2009) has gone furthest, with 46 descendants of its own.
3 other devices also cite its predicate K981941.

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

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?

For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082619: Sils Port, Models SILSPT5, SILSPT12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082619

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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