# K050578: Cook Ireland Duette Multi-Band Mucosectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Apr 22, 2005 after 46 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853585 (1986). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597, Olympus America, Inc. (1999) Summary page 1.

## Most influential descendants
- K140726: Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for Standard Gastroscopes - Box 5, Captiv (2014), 2 descendants of its own
- K190512: SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (2019), 1 descendant of its own
- K212860: SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) (2021), 0 descendants of its own
- K103155: Sumo Access and Tissue Resection System (2011), 0 descendants of its own

## Indications for use
The Duette TM Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.

Source page: https://510kreport.com/device/K050578
Methodology: https://510kreport.com/methodology