# K973366: Cobra Hand Piece

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Nov 26, 1997 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VidaMed TUNA System: named in the summary without a submission number
- (no number) VidaMed RF Generator: named in the summary without a submission number
- (no number) TUNA Catheter Hand Piece: named in the summary without a submission number

## Indications for use
The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Source page: https://510kreport.com/device/K973366
Methodology: https://510kreport.com/methodology