510(k) · Cleared
Recalled · Class II · 2025Modular 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 Jan 24, 2006 as substantially equivalent to K932995 (Applied Medical Resources, 1993) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 1999. 10 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 24, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990028 (1999). 4 ancestors in all, the oldest K932995 (1993). 10 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
- 1 generation backK032889 Optical SeparatorApplied Medical Resources · 2003
- This deviceK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006
- Descendant · cites it directly · 4 of its ownK083638 Fixation TrocarsApplied Medical Resources Corp. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK072674 Kii Trocar SystemApplied Medical Resources Corp. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK252714 C-Lant PortVigor Medical Technologies, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K083638Fixation TrocarsApplied Medical Resources Corp. · 2008 · cites it directly4descendants
- K211577SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021 · 2 generations on2descendants
- K072674Kii Trocar SystemApplied Medical Resources Corp. · 2007 · cites it directly2descendants
- K252714C-Lant PortVigor Medical Technologies, Ltd. · 2026 · 2 generations on0descendants
- K233263Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990028 | Endopath Optiview Optical Surgical Obturator and Sleeve | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −1 | K032889 | Optical Separator | Applied Medical Resources | 2003 | — |
| 0 (this device) | K060096 | Modular Trocar System | Applied Medical Resources Corp. | 2006 | — |
| +1 | K083638 | Fixation Trocars | Applied Medical Resources Corp. | 2008 | 1 |
| +2 | K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021 | — |
| +1 | K072674 | Kii Trocar System | Applied Medical Resources Corp. | 2007 | 2 |
| +2 | K252714 | C-Lant Port | Vigor Medical Technologies, Ltd. | 2026 | — |
| +3 | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K932995 | Surgical Trocar and CannulaSummary page 1…CFR 876.1500) TRADE NAME: Modular Trocar System PREDICATE DEVICE: Applied Medical Modular Trocar (K932995) Applied Medical Optical Separator (K032889) Applied Medical,… | 1993 |
| * | K032889 | Optical SeparatorSummary page 1…Modular Trocar System PREDICATE DEVICE: Applied Medical Modular Trocar (K932995) Applied Medical Optical Separator (K032889) Applied Medical, Rancho Santa Margarita, CA INTENDED USE: The Modular Trocar System is a steri… | 2003 |
What descends from it? (10)
6 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2025 | Class II | Z-1010-2026 | Nonconforming Material/Component | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
| May 4, 2017 | Class II | Z-2533-2017 | Under Investigation by firm | Due to possibility of insufficient sterilization. |
| Dec 18, 2009 | Not classified | Z-3066-2011 | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii… |
| Dec 18, 2009 | Not classified | Z-3068-2011 | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii… |
| Dec 18, 2009 | Not classified | Z-3067-2011 | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii… |
| Dec 18, 2009 | Not classified | Z-3069-2011 | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii… |
| Jun 4, 2009 | Not classified | Z-2226-2009 | Component design/selection | Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K083638 (Applied Medical Resources Corp., 2008) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K932995.
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 Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold© cannula and is intended for use in conjunction with Applied's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060096: Modular Trocar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060096
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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