510(k) · Cleared
ClearedGelport Single Incision Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 18, 2009 as substantially equivalent to K014047 (Applied Medical Resources Corp., 2002) after a 14-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Feb 18, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954824 (1996). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- 3 generations backK962147 Dexterity Pneumo Sleeve SetMedical Creative Technologies, Inc. · 1996
- 2 generations backK990414 Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999
- 1 generation backK014047 Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002
- This deviceK090275 Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009
- Descendant · cites it directly · 0 of its ownK202688 AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
- Descendant · cites it directly · 0 of its ownK100180 Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co., Ltd. · 2021 · cites it directly0descendants
- K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp. · 2012 · cites it directly0descendants
- K100180Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| −3 | K962147 | Dexterity Pneumo Sleeve Set | Medical Creative Technologies, Inc. | 1996 | — |
| −2 | K990414 | Smith & Nephew Handport System | Smith & Nephew, Inc. | 1999 | — |
| −1 | K014047 | Applied Gelport Laparoscopic Hand Access Device | Applied Medical Resources Corp. | 2002 | — |
| 0 (this device) | K090275 | Gelport Single Incision Access System | Applied Medical Resources Corp. | 2009 | — |
| +1 | K202688 | AFS Medical Sterile Single-Use Access Port System | Afs Medical Co., Ltd. | 2021 | — |
| +1 | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +1 | K100180 | Surgiquest Anchorport Sil Kit | Surgiquest, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K014047 | Applied Gelport Laparoscopic Hand Access DeviceSummary page 1…Laparoscope, General & Pl~astic Surgery (21CFR 876.1500, product code GCJ) PREDICATE DEVICE: K014047, Applied GelPort Laparoscopic Hand Access Device DEVICE DESCRIPTION: The subject device is… | 2002 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K202688 (Afs Medical Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K014047.
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?
For use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by instrumentation. Trocars may be placed through the Gel Seal Cap to allow instrument access to the surgical site, The device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090275 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090275: Gelport Single Incision Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090275
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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