# K211577: SoftFix Balloon Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Systems, Inc.
- Decided: Nov 5, 2021 after 168 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K990028 (1999). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060629: Gelport Blunt Tip Trocar System, Applied Medical Resources Corp. (2006) Summary page 4.
- K083638: Fixation Trocars, Applied Medical Resources Corp. (2008) Summary page 4.

## Most influential descendants
- K252714: C-Lant Port (2026), 0 descendants of its own
- K233263: Disposable Trocars (2024), 0 descendants of its own

## Indications for use
The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.

Source page: https://510kreport.com/device/K211577
Methodology: https://510kreport.com/methodology