510(k) · Cleared
ClearedGelport Blunt Tip Trocar 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 Apr 7, 2006 as substantially equivalent to K924011 (Origin Medsystems, Inc., 1993) after a 29-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924011 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924011 Origin Blunt Tip Surgical TrocarOrigin Medsystems, Inc. · 1993 · Recalled
- This deviceK060629 Gelport Blunt Tip Trocar SystemApplied Medical Resources Corp. · 2006
- Descendant · cites it directly · 2 of its ownK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK252714 C-Lant PortVigor Medical Technologies, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK191866 GelPOINT Mini Advanced Access PlatformApplied Medical · 2020
Most influential descendants
Showing 4 of 4 · See all- K211577SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021 · cites it directly2descendants
- K252714C-Lant PortVigor Medical Technologies, Ltd. · 2026 · 2 generations on0descendants
- K233263Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024 · 2 generations on0descendants
- K191866GelPOINT Mini Advanced Access PlatformApplied Medical · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924011 | Origin Blunt Tip Surgical Trocar | Origin Medsystems, Inc. | 1993 | 7 |
| 0 (this device) | K060629 | Gelport Blunt Tip Trocar System | Applied Medical Resources Corp. | 2006 | — |
| +1 | K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021 | — |
| +2 | K252714 | C-Lant Port | Vigor Medical Technologies, Ltd. | 2026 | — |
| +2 | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
| +1 | K191866 | GelPOINT Mini Advanced Access Platform | Applied Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K924011 | Origin Blunt Tip Surgical TrocarSummary page 1…eral & Plastic Surgery (21CFR 876. 1500) TRADE NAME: GelPort® Blunt Tip Trocar System PREDICATE DEVICE: United States Surgical Blunt Tip Trocar (K92401 1) Originally filed under Origin Medsystems, Incorporated INTENDED USE: The GelPort Blunt Tip Trocar Sys… | 1993 |
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?
- Its one ancestor has a recall.
- Of its descendants, K211577 (Unimax Medical Systems, Inc., 2021) has gone furthest, with 2 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 GelPort Blunt Tip Trocar System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060629: Gelport Blunt Tip Trocar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060629
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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