AUTOMATED TRU-CUT BIOPSY DEVICE— 510(k) K954529

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K954529 for AUTOMATED TRU-CUT BIOPSY DEVICE, Substantially Equivalent on 1995-12-29. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1995-09-29
Decision date: 1995-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.