# K063477: Novamed Mri Conditional Laryngoscope Set

- Pathway: 510(k) (Traditional)
- Applicant: Novamed, LLC
- Decided: Feb 9, 2007 after 85 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
Longest line of descent: 1 generation back to K041852 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041852: MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002, Minrad, Inc. (2004) Summary page 1.

## Indications for use
The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Source page: https://510kreport.com/device/K063477
Methodology: https://510kreport.com/methodology