# K991548: Hal Scope Holder System

- Pathway: 510(k) (Traditional)
- Applicant: Noved Medical
- Decided: Jun 23, 1999 after 51 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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) Hydromed Product's Universal Drape: named in the summary without a submission number

## Indications for use
The HAL Scope Holder System is intended for use during medical procedure where sterile barrier is required on manipulating/ movable arms. It is for single use only.

Source page: https://510kreport.com/device/K991548
Methodology: https://510kreport.com/methodology