# K072937: Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set

- Pathway: 510(k) (Traditional)
- Applicant: Olsen Medical
- Decided: Dec 28, 2007 after 73 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 K052449 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052449: Cadman Integrated Irrigation Tubing and Bipolar Cord Set, Models 80-1163, 80-1189, Codman & Shurtleff, Inc. (2005) Summary page 1.

## Indications for use
The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set (Catalog No. 40-3xxx) is a single use product sold sterile and is intended for use with a standard bipolar irrigating forceps like the OLSEN MEDICAL Bipolar Irrigating Forceps and the Codman & Shurtleff, MalisTM CMC® Bipolar Systems to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. This device is intended for use with the Codman/MalisTM CMC® -II and the CODMAN/MALISTM CMC®-III Bipolar Cut and Coagulation System (or equivalent) Electrosurgical Generator. Bipolar forceps specifically designed for irrigating are required for use with this tubing and cord set. Please read the instruction manuals supplied with the irrigation module and the bipolar coagulator or electrosurgical systems before using this product.

Source page: https://510kreport.com/device/K072937
Methodology: https://510kreport.com/methodology