NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET— 510(k) K063477

Name: FDA 510(k) clearance K063477
Creator: U.S. Food and Drug Administration
Published: 2007-02-09

Substantially Equivalent

Novamed, LLC

FDA 510(k) clearance K063477 for NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET, Substantially Equivalent on 2007-02-09. Applicant: Novamed, LLC. Device class: 1.

Clearance details

Applicant: Novamed, LLC
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 2006-11-16
Decision date: 2007-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCW

view all

K191602 — APA Oxy Blade2019-08-02
K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)2017-06-22
K140951 — YEESCOPE LARYNGOSCOPES2014-11-10
K121378 — AIRTRAQ SP AIRTRAQ AVANT2012-06-21
K062523 — TRU-MR LARYNGOSCOPE SET2006-11-17

More clearances from Novamed, LLC

view all

K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE2006-09-05

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.