# K061787: Maxforce TTS Single-Use Balloon Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 21, 2006 after 87 days
- Product code: KNQ (Dilator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.5365
- 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 K934697 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K934697: Microvasive Maxforce, Boston Scientific Corp (1994) Summary page 1.

## Most influential descendants
- K111030: E.G. Scan (TM) Esophagoscope System (2011), 2 descendants of its own
- K120702: E.G. Scan II Esphagoscope System (2012), 1 descendant of its own
- K131131: E.G. Scan (TM) II Esophagoscope System (2013), 0 descendants of its own

## Indications for use
The proposed Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

Source page: https://510kreport.com/device/K061787
Methodology: https://510kreport.com/methodology