KOMET XK-95 PERFORATOR MOTOR (MI-102)— 510(k) K991625

Name: FDA 510(k) clearance K991625
Creator: U.S. Food and Drug Administration
Published: 1999-07-30

Substantially Equivalent

Komet Medical

FDA 510(k) clearance K991625 for KOMET XK-95 PERFORATOR MOTOR (MI-102), Substantially Equivalent on 1999-07-30. Applicant: Komet Medical. Device class: 2.

Clearance details

Applicant: Komet Medical
Product code: Code HBB
Device class: Class 2
Regulation: 21 CFR 882.4370
Advisory panel: Neurology
Date received: 1999-05-11
Decision date: 1999-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Savannah, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.