510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943541Substantially Equivalent

75K Staight Drill

Stryker Corp., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943541 is the FDA 510(k) clearance record for 75K STAIGHT DRILL, a class II device, cleared for Stryker Corp. on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K943541.

Clearance record

Decision date
Received
(300 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
Stryker Corp. 4100 E Milham Ave., Portage MI
510(k) summary
Summary
Third party review
No

Clearances, product code HBE

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