# K041810: Serfas Energy System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Dec 21, 2004 after 168 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: 6 generations back to K011083 (2001). 16 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991960: Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch, Stryker Endoscopy (1999) Summary page 1.
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20, Arthrocare Corp. (2000) Summary page 1.
- K011634: Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model H2000-04; Powercord, Model H2000, Arthrocare Corp. (2001) Summary page 1.
- K020832: Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands, Arthrocare Corp. (2002) Summary page 1.
- K032504: Arthrocare System, Arthrocare Corp. (2003) Summary page 1.
- K011083: Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand, Arthrocare Corp. (2001) Summary page 1.
- K013463: Arthrocare Arthro Wands, Enetec Evac Plasma Wand, Arthrocare Corp. (2001) Summary page 1.
- K020557: Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands, Arthrocare Corp. (2002) Summary page 1.
- K030551: Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands, Arthrocare Corp. (2003) Summary page 1.
- K033584: Arthrocare Arthrowands, Arthrocare Corp. (2003) Summary page 1.
- K974022: VAPR, Mitek Products (1998) Summary page 1.

## Most influential descendants
- K113545: Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System Coolpluse 90 and Coolpluse 90 with Han (2012), 7 descendants of its own
- K071859: Stryker Crossfire System (2007), 4 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own
- K162770: Relign System (2017), 2 descendants of its own
- K161558: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating,  Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating (2016), 2 descendants of its own

## Recalls of this device
- Jun 3, 2015 · Class II · Z-1831-2015: Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
- Jun 20, 2008 · Not classified · Z-0972-2009: The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.
- Apr 26, 2007 · Not classified · Z-0484-2008: Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)

## Indications for use
The SERFAS Energy System is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.

Source page: https://510kreport.com/device/K041810
Methodology: https://510kreport.com/methodology