RAPIDFLAP CRANIAL CLAMP— 510(k) K991029

Substantially Equivalent

Walter Lorenz Surgical, Inc.

FDA 510(k) clearance K991029 for RAPIDFLAP CRANIAL CLAMP, Substantially Equivalent on 1999-04-23. Applicant: Walter Lorenz Surgical, Inc..

Clearance details

Applicant: Walter Lorenz Surgical, Inc.
Product code: Code GXN
Advisory panel: Neurology
Date received: 1999-03-29
Decision date: 1999-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Jacksonville, FL, US

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.