# K133375: Banyan Medical Disposable Secondary Cannula and Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Banyan Medical, LLC
- Decided: Jan 17, 2014 after 74 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920110 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911462: Surgical Trocar, Applied Medical (1991) Summary page 1.
- K112358: Unimax Trocar System, Unimax Medical Systems, Inc. (2011) Summary page 1.

## Recalls of this device
- Sep 7, 2016 · Class II · Z-0074-2017: Potential lack of assurance of sterility
- Sep 7, 2016 · Class II · Z-0075-2017: Potential lack of assurance of sterility

## Indications for use
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.

Source page: https://510kreport.com/device/K133375
Methodology: https://510kreport.com/methodology