# K083292: Habib Endohpb

- Pathway: 510(k) (Traditional)
- Applicant: Emcision, Ltd.
- Decided: Jun 10, 2009 after 212 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970278 (1997). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072383: Habib Endoblate, Emcision, Ltd. (2007) Summary page 1.

## Most influential descendants
- K180165: Habib EndoHPB (2018), 3 descendants of its own
- K181758: ELRA Electrode (2019), 1 descendant of its own
- K233113: ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) (2023), 0 descendants of its own
- K231533: Habib EndoHPB (2023), 0 descendants of its own

## Recalls of this device
- Feb 2, 2023 · Class II · Z-1397-2023: Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccur

## Indications for use
The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.

Source page: https://510kreport.com/device/K083292
Methodology: https://510kreport.com/methodology