# K963765: Stryker Strykeflow Electrocautery Probes

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jan 31, 1997 after 134 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934094 (1994). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934094: Stryker Laparoscopic Suction Irrigator, Stryker Corp. (1994) Summary page 1.
- K954726: Stryker Strykeflow Suction Irrigator (Modification), Stryker Endoscopy (1995) Summary page 1.
- (no number) Valleylab Laparoscopic Handswitch/Electrodes: named in the summary without a submission number

## Most influential descendants
- K100711: Suction Irrigation Electrodes and Adapters (2010), 1 descendant of its own
- K052141: Stryker Stiletto Electrosurgical Probe (2005), 1 descendant of its own
- K190168: Aquas Probes (2019), 0 descendants of its own
- K131949: Aem Disposable Suction Irrigation Electrodes (2013), 0 descendants of its own
- K102275: Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240 (2011), 0 descendants of its own

## Recalls of this device
- Sep 12, 2019 · Class II · Z-1508-2020: 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 

## Indications for use
The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single probe is desirable.

Source page: https://510kreport.com/device/K963765
Methodology: https://510kreport.com/methodology