Cleared Traditional

K063477 - NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

K063477 is an FDA 510(k) clearance for NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET, manufactured by Novamed, LLC. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K063477 · Novamed, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
85d
Days
Class 1
Risk

K063477 is an FDA 510(k) clearance for the NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Novamed, LLC (Bonita Springs, US). The FDA issued a Cleared decision on February 9, 2007 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Novamed, LLC devices

FDA 510(k) Submission Details - K063477

510(k) Number K063477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2006
Decision Date February 09, 2007
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCW Laryngoscope, Rigid

All 15
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K063477.
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K945425 · Rudolf Riester GmbH & Co. KG · Mar 1995
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