510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213228Substantially Equivalent

NeuroLine Disposable Cranial Perforator with Hudson end

EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft., Debrecen, HU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213228 is the FDA 510(k) clearance record for NeuroLine Disposable Cranial Perforator with Hudson end, a class II device, cleared for Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. on under FDA product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)). FDA records list one 510(k) clearance for Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. As of , FDA records show no recalls naming K213228.

Clearance record

Decision date
Received
(264 days to decision)
Product code
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Regulation
21 CFR 882.4305
Device class
Class II
Review panel
Neurology
Applicant
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. Bartok Bela U. 113/B, Debrecen, HU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBF

Trailing 12 months
1 clearance under product code HBF 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 HBF, 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