# K020304: Disposable Light Handle and Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Surgical Products, Inc.
- Decided: Feb 14, 2002 after 16 days
- Product code: FTA (Light, Surgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Dispasable Light Handle is a single use sterile product. It Is intended to be used as an accessory to Surgical Lamps. This Diqumble Handle pravmes a stetile interface between the operating room Surgical Lamy (non-sterile), and the Surgeon or Scrub Nuxse (sterile)

Source page: https://510kreport.com/device/K020304
Methodology: https://510kreport.com/methodology