# K211170: Single Use Irrigation bipolar cable

- Pathway: 510(k) (Traditional)
- Applicant: Modern Medical Equipment Manufacturing, Ltd.
- Decided: Oct 19, 2021 after 183 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K251492: Irrigation Tubing Bipolar Cord Set (2026), 0 descendants of its own

## Indications for use
The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.

Source page: https://510kreport.com/device/K211170
Methodology: https://510kreport.com/methodology