# K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Dec 19, 2008 after 144 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: 2 generations back to K993720 (2000). 6 ancestors in all.
2 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)
- K993720: Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Corp. (2000) Summary page 1.
- K023907: Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon Dilation Catheter, Cordis Corp. (2002) Summary page 1.
- K073046: Ethicon Endo Surgery Articulating Needle Knife, Model 2504, Ethicon Endo-Surgery, Inc. (2008) Summary page 1.

## Most influential descendants
- K103155: Sumo Access and Tissue Resection System (2011), 0 descendants of its own
- K093279: Navix Access Device (2010), 0 descendants of its own

## Indications for use
The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Source page: https://510kreport.com/device/K082114
Methodology: https://510kreport.com/methodology