# K991847: Thermoflex System

- Pathway: 510(k) (Traditional)
- Applicant: Argomed, Inc.
- Decided: Aug 26, 1999 after 90 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: 3 generations back to K951245 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965199: Tuna 5 Catheter, Vidamed, Inc. (1997) Summary page 3.
- K960918: Vidamed Tuna (Transurethral Needle Ablation) System, Vidamed, Inc. (1996) Summary page 3.
- K951245: Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) Accessory, Vidamed, Inc. (1995) Summary page 1.
- K954597: Right Angle Laser Fibers, Trimedyne, Inc. (1996) Summary page 1.
- K913477: Apex (TM) Prostatic Balloon Dilation Catheter, Peripheral Systems Group (1991) Summary page 1.

## Indications for use
The Thermoflex system is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (‘BPH”). It is indicated for use in men over the age of 50 years with prostate lengths between 2.0 cm and 6.4 cm who present symptoms of urinary outflow obstruction secondary to BPH.

Source page: https://510kreport.com/device/K991847
Methodology: https://510kreport.com/methodology