510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163565Substantially Equivalent

MR8 Drill System

Medtronic Powered Surgical Solutions, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163565 is the FDA 510(k) clearance record for MR8 Drill System, a class II device, cleared for Medtronic Powered Surgical Solutions on under FDA product code HBC (Motor, Drill, Electric). FDA records list 9 510(k) clearances for Medtronic Powered Surgical Solutions, from to . As of , FDA records show no recalls naming K163565.

Clearance record

Decision date
Received
(99 days to decision)
Product code
HBC Motor, Drill, Electric
Regulation
21 CFR 882.4360
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Powered Surgical Solutions 4620 N Beach St., Fort Worth TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBC

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