# K201511: Reprocessed Endoscopic Trocars and Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Jul 31, 2020 after 56 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032676 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 5.
- K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath, Ethicon Endo-Surgery, LLC (2012) Summary page 5.

## Recalls of this device
- Aug 19, 2026 · Class II · Z-3187-2026: Reusable access port system may crack or seperate during use.
- Aug 19, 2026 · Class II · Z-3186-2026: Reusable access port system may crack or seperate during use.
- Aug 19, 2026 · Class II · Z-3185-2026: Reusable access port system may crack or seperate during use.
- Aug 19, 2026 · Class II · Z-3183-2026: Reusable access port system may crack or seperate during use.
- Aug 19, 2026 · Class II · Z-3182-2026: Reusable access port system may crack or seperate during use.
- Aug 19, 2026 · Class II · Z-3184-2026: Reusable access port system may crack or seperate during use.

## Indications for use
The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K201511
Methodology: https://510kreport.com/methodology