510(k) · Cleared
ClearedSils Port Model SILSPT15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS Tyco Healthcar · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 3, 2009 as substantially equivalent to K082619 (Covidien Lp, Formerly Registered AS United States, 2008) and 1 other predicate after a 35-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it.
- Decided
- Dec 3, 2009
- Review
- 35 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940232 (1994). 24 ancestors in all, the oldest K883018 (1988). 9 later devices descend from it, 3 citing it directly.
- 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 deviceK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- Descendant · cites it directly · 4 of its ownK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- Descendant · cites it directly · 3 of its ownK141715 Glove PortNelis · 2015
- Descendant · 2 generations on · 3 of its ownK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- Descendant · 3 generations on · 1 of its ownK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
- Descendant · cites it directly · 0 of its ownK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K103253Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011 · cites it directly4descendants
- K141715Glove PortNelis · 2015 · cites it directly3descendants
- K110792Gelpoint PathApplied Medical Resources Corp. · 2011 · 2 generations on3descendants
- K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014 · 3 generations on1descendant
- K233263Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024 · cites it directly0descendants
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) | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| +1 | K103253 | Sils Port | Coviden (Formerly Registered AS US Surgical, A Div | 2011 | — |
| +1 | K141715 | Glove Port | Nelis | 2015 | — |
| +2 | K110792 | Gelpoint Path | Applied Medical Resources Corp. | 2011 | — |
| +3 | K133393 | Gelpoint Path Transanal Access Platform | Applied Medical Resources Corp. | 2014 | — |
| +1 | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K082619 | Sils Port, Models SILSPT5, SILSPT12Summary page 1…/USUAL NAME: Surgical Trocar CLASSIFICATION NAME: Endloscope and/or accessories PREDICATE DEVICE(S): Covidien SILS"M Port (K082619) Dexide Trocar (K981941) DEVICE DESCRIPTION: Three laparoscopic trocars and… | 2008 |
| * | K981941 | Multaport Cannula Reducer and AccessoriesSummary page 1…NAME: Endloscope and/or accessories PREDICATE DEVICE(S): Covidien SILS"M Port (K082619) Dexide Trocar (K981941) DEVICE DESCRIPTION: Three laparoscopic trocars and an insuflation tube bound by a… | 1998 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 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, K103253 (Coviden (Formerly Registered AS US Surgical, A Div, 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K082619.
How does its category compare?
All GCJ devicesGCJ 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 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 SILS Port is indicated 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/K093372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093372: Sils Port Model SILSPT15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093372
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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