FDA 510(k)

XK-95 HIGH SPEED MOTOR DRILL SYSTEM

K-Number: K984035 · 1999-06-03

Decision Date1999-06-03

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

XK-95 HIGH SPEED MOTOR DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Komet Medical. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K984035. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XK-95 HIGH SPEED MOTOR DRILL SYSTEM?

XK-95 HIGH SPEED MOTOR DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Komet Medical. The 510(k) number is K984035.

When did XK-95 HIGH SPEED MOTOR DRILL SYSTEM receive FDA 510(k) clearance?

XK-95 HIGH SPEED MOTOR DRILL SYSTEM received FDA 510(k) clearance on 1999-06-03, under 510(k) number K984035.

Who is the listed applicant for XK-95 HIGH SPEED MOTOR DRILL SYSTEM?

The FDA 510(k) record lists Komet Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XK-95 HIGH SPEED MOTOR DRILL SYSTEM?

The FDA product code for XK-95 HIGH SPEED MOTOR DRILL SYSTEM is HBE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Komet Medical as applicant

K991625KOMET XK-95 PERFORATOR MOTOR (MI-102)K943758SURGICAL BUR

Related Devices (Code: HBE)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.