510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151536Substantially Equivalent

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

Mri Interventions, Inc., Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151536 is the FDA 510(k) clearance record for SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm, a class II device, cleared for Mri Interventions, Inc. on under FDA product code HBG (Drills, Burrs, Trephines & Accessories (Manual)). FDA records list 14 510(k) clearances for Mri Interventions, Inc., from to . As of , FDA records show no recalls naming K151536.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HBG Drills, Burrs, Trephines & Accessories (Manual)
Regulation
21 CFR 882.4300
Device class
Class II
Review panel
Neurology
Applicant
Mri Interventions, Inc. 5 Musick, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBG

Trailing 12 months
1 clearance under product code HBG 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 HBG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260