# K051420: Habib 4X

- Pathway: 510(k) (Traditional)
- Applicant: Emcision, Ltd.
- Decided: Aug 15, 2005 after 75 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071103: Habib Hexablate (2007), 2 descendants of its own
- K062935: Habib 4X Laparoscopic (2006), 1 descendant of its own
- K080717: Habib Hexablate 10 (2008), 0 descendants of its own
- K073687: Habib Laparoscopic Hexablate (2008), 0 descendants of its own

## Recalls of this device
- Aug 30, 2010 · Not classified · Z-3074-2011: The labeling contains errors which result in the products being misbranded
- Aug 30, 2010 · Not classified · Z-3073-2011: The labeling contains errors which result in the products being misbranded
- Sep 21, 2005 · Not classified · Z-0031-06: Devices for which sterility may be compromised as evidenced by a loss of package integrity.

## Indications for use
The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

Source page: https://510kreport.com/device/K051420
Methodology: https://510kreport.com/methodology