COHORT BONE BRUSH— 510(k) K942108

Substantially Equivalent

Advanced Med/Surg, Inc.

FDA 510(k) clearance K942108 for COHORT BONE BRUSH, Substantially Equivalent on 1994-10-11. Applicant: Advanced Med/Surg, Inc..

Clearance details

Applicant: Advanced Med/Surg, Inc.
Product code: Code HWE
Advisory panel: General, Plastic Surgery
Date received: 1994-05-02
Decision date: 1994-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

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Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.