OROTRACHEAL INTUBATION ENDOSCOPE— 510(k) K801452

Name: FDA 510(k) clearance K801452
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K801452 for OROTRACHEAL INTUBATION ENDOSCOPE, Substantially Equivalent on 1980-07-14. Applicant: Olympus Corp.. Device class: 1.

Clearance details

Applicant: Olympus Corp.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1980-06-23
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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
K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET2007-02-09

More clearances from Olympus Corp.

view all

K915402 — EW-10 AND EW-201995-06-23
K933200 — OLYMPUS PBD STENTS1995-04-05
K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES1994-11-30
K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS1994-08-29
K934835 — FLOVAL1994-06-21

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.