VIDEO ENDOSCOPE SYSTEM— 510(k) K922418

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K922418 for VIDEO ENDOSCOPE SYSTEM, Substantially Equivalent on 1993-07-29. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1992-05-21
Decision date: 1993-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.