# K970069: Dual Hook Fiberoptic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Ihd, Inc.
- Decided: Jul 17, 1998 after 555 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgieal applications. This includes incision, excision, or coagulation of tissue.

Source page: https://510kreport.com/device/K970069
Methodology: https://510kreport.com/methodology