# K945741: Trocar and Cannula Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Feb 28, 1995 after 97 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 25, 2008 · Not classified · Z-0023-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0025-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0026-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in
- Jun 25, 2008 · Not classified · Z-0024-2009: Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of in

Source page: https://510kreport.com/device/K945741
Methodology: https://510kreport.com/methodology