# K934094: Stryker Laparoscopic Suction Irrigator

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Feb 18, 1994 after 179 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
37 later devices descend from it; 2 cite it directly.
0 of 38 devices 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.

## Most influential descendants
- K992126: Circon Surgiflex Wave Tsunami Suction-Irrigation System (1999), 30 descendants of its own
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp) (2006), 23 descendants of its own
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own

## Recalls of this device
- Jun 18, 2025 · Class II · Z-2170-2025: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- Sep 12, 2019 · Class II · Z-1509-2020: Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the 
- Nov 17, 2017 · Class II · Z-0835-2018: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Source page: https://510kreport.com/device/K934094
Methodology: https://510kreport.com/methodology