CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS— 510(k) K934628

Substantially Equivalent

Valleylab, Inc.

FDA 510(k) clearance K934628 for CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS, Substantially Equivalent on 1995-07-11. Applicant: Valleylab, Inc..

Clearance details

Applicant: Valleylab, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1993-09-15
Decision date: 1995-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.