# K052141: Stryker Stiletto Electrosurgical Probe

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Oct 6, 2005 after 59 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934094 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963765: Stryker Strykeflow Electrocautery Probes, Stryker Endoscopy (1997) Summary page 1.

## Most influential descendants
- K190168: Aquas Probes (2019), 0 descendants of its own

## Recalls of this device
- Feb 25, 2010 · Not classified · Z-1704-2011: The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).
- Nov 16, 2007 · Not classified · Z-0573-2008: Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
- Nov 16, 2007 · Not classified · Z-0574-2008: Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.

## Indications for use
The Stryker Stiletto Electrosurgical Probe is indicated for use in laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, laparoscopic thoracic surgery, gynecological surgery, general surgery and urological surgery. The device allows for suction and irrigation of sterile irrigant solution. In addition, the device is intended to be used for electrosurgical cutting/coagulation during laparoscopic procedures.

Source page: https://510kreport.com/device/K052141
Methodology: https://510kreport.com/methodology