# K031564: CSS

- Pathway: 510(k) (Special)
- Applicant: Medical Scientific, Inc.
- Decided: Oct 7, 2003 after 141 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991960 (1999). 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)
- K011202: Msi Bipolar Sheath, Medical Scientific, Inc. (2001)
- K991960: Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch, Stryker Endoscopy (1999) Summary page 1.

## Indications for use
The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during arthroscopic surgical procedures.

Source page: https://510kreport.com/device/K031564
Methodology: https://510kreport.com/methodology