# K993089: Deroyal Disposable Rigid Light Handle and Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Cardiovascular, Inc.
- Decided: Oct 14, 1999 after 28 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. The FDA summary names its predicate without a number.
- (no number) Charles Polo & Co.: named in the summary without a submission number
- (no number) Devon Industries: named in the summary without a submission number

## Indications for use
The DeRoyal Disposable Rigid Light Handle and Adapter are indicated for use as accessories to a surgical lamp. The adapter is to be used, when necessary, to attach the light handle to the surgical lamp. The light handle is to be used to position the light without contaminating the gloved hand.

Source page: https://510kreport.com/device/K993089
Methodology: https://510kreport.com/methodology