510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082010Substantially Equivalent

Stryker Disposable Cranial Perforator Bit

Stryker Ireland Ltd., Instruments Division, Carrigtwohill, Co.Cork, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082010 is the FDA 510(k) clearance record for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT, a class II device, cleared for Stryker Ireland Ltd., Instruments Division on under FDA product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)). FDA records list 2 510(k) clearances for Stryker Ireland Ltd., Instruments Division, from to . As of , FDA records show one recall naming K082010.

Clearance record

Decision date
Received
(167 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
Stryker Ireland Ltd., Instruments Division Carrigtwohill Business &, Carrigtwohill, Co.Cork, IE
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