510(k) · Cleared
ClearedSurgical Trocar and Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 23, 1993 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Sep 23, 1993
- Review
- 97 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK932995 Surgical Trocar and CannulaApplied Medical Resources · 1993
- Descendant · cites it directly · 10 of its ownK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006 · Recalled
- Descendant · 2 generations on · 4 of its ownK083638 Fixation TrocarsApplied Medical Resources Corp. · 2008 · Recalled
- Descendant · 3 generations on · 2 of its ownK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK072674 Kii Trocar SystemApplied Medical Resources Corp. · 2007 · Recalled
- Descendant · cites it directly · 2 of its ownK012968 Applied Access SealApplied Medical Resources Corp. · 2001
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K060096Modular Trocar SystemApplied Medical Resources Corp. · 2006 · cites it directly10descendants
- K083638Fixation TrocarsApplied Medical Resources Corp. · 2008 · 2 generations on4descendants
- K211577SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021 · 3 generations on2descendants
- K072674Kii Trocar SystemApplied Medical Resources Corp. · 2007 · 2 generations on2descendants
- K012968Applied Access SealApplied Medical Resources Corp. · 2001 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932995 | Surgical Trocar and Cannula | Applied Medical Resources | 1993 | — |
| +1 | K060096 | Modular Trocar System | Applied Medical Resources Corp. | 2006 | 7 |
| +2 | K083638 | Fixation Trocars | Applied Medical Resources Corp. | 2008 | 1 |
| +3 | K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021 | — |
| +2 | K072674 | Kii Trocar System | Applied Medical Resources Corp. | 2007 | 2 |
| +1 | K012968 | Applied Access Seal | Applied Medical Resources Corp. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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?
- Of its descendants, K060096 (Applied Medical Resources Corp., 2006) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K932995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932995: Surgical Trocar and Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932995
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026