510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955012Substantially Equivalent

Mizuho Radiolucent Head Frame

Mizuho America, Inc., Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955012 is the FDA 510(k) clearance record for MIZUHO RADIOLUCENT HEAD FRAME, a class II device, cleared for Mizuho America, Inc. on under FDA product code HBL (Holder, Head, Neurosurgical (Skull Clamp)). FDA records list 5 510(k) clearances for Mizuho America, Inc., from to . As of , FDA records show no recalls naming K955012.

Clearance record

Decision date
Received
(316 days to decision)
Product code
HBL Holder, Head, Neurosurgical (Skull Clamp)
Regulation
21 CFR 882.4460
Device class
Class II
Review panel
Neurology
Applicant
Mizuho America, Inc. 123 Brimbal Ave., Beverly MA
510(k) summary
Summary
Third party review
No

Clearances, product code HBL

Trailing 12 months
1 clearance under product code HBL 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 HBL, 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