510(k) · Cleared
ClearedGlove Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nelis · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 25, 2015 as substantially equivalent to K073719 (Advanced Surgical Concepts, 2008) and 2 other predicates after a 273-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Mar 25, 2015
- Review
- 273 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K940232 (1994). 28 ancestors in all, the oldest K883018 (1988). 3 later devices descend from it, 3 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 deviceK141715 Glove PortNelis · 2015
- Descendant · cites it directly · 0 of its ownK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220081 Core-SportIncore Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK152598 Endo KeeperNelis · 2016
Most influential descendants
Showing 3 of 3 · See allView 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) | K141715 | Glove Port | Nelis | 2015 | — |
| +1 | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
| +1 | K220081 | Core-Sport | Incore Co., Ltd. | 2022 | — |
| +1 | K152598 | Endo Keeper | Nelis | 2016 | — |
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 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K073719 | Asc Triport Laparoscopic Access DeviceSummary page 4…Code : OTJ 5) Regulation Number : 876.1500 6) Class of device : Class II 7) Panel : General & Plastic Surgery 3. The legally marketed predicate devices : ① K073719 ASC TriPort Laparoscopic Access Device, ② K093372 SILSTM Port ③ K112196 OctoTMPort 4. Device description : The Glove Por… | 2008 |
| * | K093372 | Sils Port Model SILSPT15Summary page 4…Class of device : Class II 7) Panel : General & Plastic Surgery 3. The legally marketed predicate devices : ① K073719 ASC TriPort Laparoscopic Access Device, ② K093372 SILSTM Port ③ K112196 OctoTMPort 4. Device description : The Glove Port is intended to provide access for multiple instrume… | 2009 |
| * | K112196 | OctotmportSummary page 4…II 7) Panel : General & Plastic Surgery 3. The legally marketed predicate devices : ① K073719 ASC TriPort Laparoscopic Access Device, ② K093372 SILSTM Port ③ K112196 OctoTMPort 4. Device description : The Glove Port is intended to provide access for multiple instruments and/or endoscope to… | 2011 |
What descends from it? (3)
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 21 years and passes through 7 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K233263 (Hangzhou Kangji Medical Instrument Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K073719.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141715: Glove Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141715
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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