510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984035Substantially Equivalent

Xk-95 High Speed Motor Drill System

Komet Medical, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984035 is the FDA 510(k) clearance record for XK-95 HIGH SPEED MOTOR DRILL SYSTEM, a class II device, cleared for Komet Medical on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list 3 510(k) clearances for Komet Medical, from to . As of , FDA records show no recalls naming K984035.

Clearance record

Decision date
Received
(203 days to decision)
Product code
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
Komet Medical 1679 Kellogg Springs Dr., Atlanta GA
510(k) summary
Statement
Third party review
No

Clearances, product code HBE

Trailing 12 months
2 clearances under product code HBE in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBE, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260