THE WUSCOPE SYSTEM— 510(k) K941319

Name: FDA 510(k) clearance K941319
Creator: U.S. Food and Drug Administration
Published: 1994-10-04

Substantially Equivalent

Achi Corp.

FDA 510(k) clearance K941319 for THE WUSCOPE SYSTEM, Substantially Equivalent on 1994-10-04. Applicant: Achi Corp.. Device class: 1.

Clearance details

Applicant: Achi Corp.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1994-03-18
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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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.