DAP II BIOPSY GUIDE— 510(k) K830999

Substantially Equivalent

Rapid Machine & Tool Corp.

FDA 510(k) clearance K830999 for DAP II BIOPSY GUIDE, Substantially Equivalent on 1983-07-12. Applicant: Rapid Machine & Tool Corp..

Clearance details

Applicant: Rapid Machine & Tool Corp.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1983-03-29
Decision date: 1983-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.