510(k) · Cleared
Recalled · Class II · 2016Banyan Medical Disposable Secondary Cannula and Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Banyan Medical, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 17, 2014 as substantially equivalent to K911462 (Applied Medical, 1991) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1992. It has been recalled 2 times.
- Decided
- Jan 17, 2014
- Review
- 74 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920110 (1992). 5 ancestors in all, the oldest K911462 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920110 | Endopath Disposable Thoracic Trocar Sleeve | ETHICON, Inc. | 1992 | — |
| −1 | K112358 | Unimax Trocar System | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K133375 | Banyan Medical Disposable Secondary Cannula and Trocar | Banyan Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K911462 | Surgical TrocarSummary page 1…GCJ Classification Name: Laparoscope, General & Plastic Surgery Substantial Equivalence K91 1462; Apple Medical Surgical Trocar Claimed To: K1 12358; Unimax Seco… | 1991 |
| * | K112358 | Unimax Trocar SystemSummary page 1…Substantial Equivalence K91 1462; Apple Medical Surgical Trocar Claimed To: K1 12358; Unimax Secondary Trocar 51 0(k) Summary Pagel1 of 3… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2016 | Class II | Z-0074-2017 | Process control | Potential lack of assurance of sterility |
| Sep 7, 2016 | Class II | Z-0075-2017 | Process control | Potential lack of assurance of sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133375 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133375: Banyan Medical Disposable Secondary Cannula and Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133375
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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