# K970619: Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Greatbatch Technologies, Inc.
- Decided: Nov 19, 1997 after 274 days
- Product code: CCW (Laryngoscope, Rigid)
- Device class: 1
- Regulation: 21 CFR 868.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Fiber Optic Laryngoscope: named in the summary without a submission number
- (no number) Sun Lite™ Laryngoscope: named in the summary without a submission number
- (no number) Heine Fiber Optic Laryngoscope: named in the summary without a submission number

## Most influential descendants
- K062231: MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001 (2006), 0 descendants of its own

## Indications for use
The Greatbatch Scientific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.

Source page: https://510kreport.com/device/K970619
Methodology: https://510kreport.com/methodology