510(k) · Cleared
ClearedSils Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coviden (Formerly Registered AS US Surgical, A Div · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 24, 2011 as substantially equivalent to K000180 (Richard Wolf Medical Instruments Corp., 2001) and 1 other predicate after a 113-day review. Its family tree reaches back 6 generations to 1994. 4 later devices descend from it.
- Decided
- Feb 24, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K940232 (1994). 26 ancestors in all, the oldest K883018 (1988). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 5 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 4 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 3 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 2 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 1 generation backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- This deviceK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- Descendant · cites it directly · 3 of its ownK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- Descendant · 2 generations on · 1 of its ownK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK171701 GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
Most influential descendants
Showing 4 of 4 · See all- K110792Gelpoint PathApplied Medical Resources Corp. · 2011 · cites it directly3descendants
- K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014 · 2 generations on1descendant
- K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017 · 2 generations on0descendants
- K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −5 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −4 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −3 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −2 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −1 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| 0 (this device) | K103253 | Sils Port | Coviden (Formerly Registered AS US Surgical, A Div | 2011 | — |
| +1 | K110792 | Gelpoint Path | Applied Medical Resources Corp. | 2011 | — |
| +2 | K133393 | Gelpoint Path Transanal Access Platform | Applied Medical Resources Corp. | 2014 | — |
| +2 | K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017 | 1 |
| +1 | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
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 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K000180 | Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set…Summary page 1…Surgical Trocar CLASS IFICATION NAME: Endoscope and/or accessories PREDICATE DEVICE(S): K(000180: Richard Wolf Medical Instrument Corp. Transanal Endoscopic Microsurgery (TEM)… | 2001 |
| * | K093372 | Sils Port Model SILSPT15Summary page 1…al Endoscopic Microsurgery (TEM) Combination System and Instrument Set K093372: Covidien SELS Tm Port DEVICE DESCRIPTION: Three laparoscopic trocars and an insufflation tube… | 2009 |
What descends from it? (4)
2 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 17 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K110792 (Applied Medical Resources Corp., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K000180.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103253: Sils Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103253
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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