510(k) · Cleared
ClearedApplied Gelport Laparoscopic Hand Access Device
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 28, 2002 as substantially equivalent to K990414 (Smith & Nephew, Inc., 1999) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 28, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954824 (1996). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- 2 generations backK962147 Dexterity Pneumo Sleeve SetMedical Creative Technologies, Inc. · 1996
- 1 generation backK990414 Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999
- This deviceK014047 Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002
- Descendant · cites it directly · 3 of its ownK090275 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 · 2 generations on · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK100180 Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K090275Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009 · cites it directly3descendants
- 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 · 2 generations on0descendants
- K100180Surgiquest Anchorport Sil KitSurgiquest, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| −2 | K962147 | Dexterity Pneumo Sleeve Set | Medical Creative Technologies, Inc. | 1996 | — |
| −1 | K990414 | Smith & Nephew Handport System | Smith & Nephew, Inc. | 1999 | — |
| 0 (this device) | K014047 | Applied Gelport Laparoscopic Hand Access Device | Applied Medical Resources Corp. | 2002 | — |
| +1 | 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 | — |
| +2 | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K990414 | Smith & Nephew Handport SystemSummary page 1…tion Number 21CFR 876.1500, Endoscope and accessories). TRADE NAME: Applied GelPort Laparoscopic Hand Access Device PREDICATE DEVICE: 1. Smith & Nephew Handport System (K990414), Smith & Nephew, Inc., Andover, MA. 2. Applied Intromit Laparoscopic Hand Access Port (K990663), Medtech Ltd., Ireland. Market… | 1999 |
| * | K990663 | Intromit Hand Access Port for Hand Assisted Laparoscopic Surgery, Model FP880-150Summary page 1…Hand Access Device PREDICATE DEVICE: 1. Smith & Nephew Handport System (K990414), Smith & Nephew, Inc., Andover, MA. 2. Applied Intromit Laparoscopic Hand Access Port (K990663), Medtech Ltd., Ireland. Marketed by Applied Medical Resources, Rancho Santa Margarita, CA. SUMMARY STATEMENT: The Applied GelPo… | 1999 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K090275 (Applied Medical Resources Corp., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Applied GelPort Laparoscopic Hand Access Device is indicated for use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by the surgeon’s hand and instrumentation. Additional slits may be made using a trocar at the periphery of the Gel Seal Cap to allow instrument access to the surgical site. The Applied GelPort Laparoscopic Hand Access 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014047: Applied Gelport Laparoscopic Hand Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014047
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026