510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103493Substantially Equivalent

Head Fiation Device (Hfd 100)

Imris, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103493 is the FDA 510(k) clearance record for HEAD FIATION DEVICE (HFD 100), a class II device, cleared for Imris, Inc. on under FDA product code HBL (Holder, Head, Neurosurgical (Skull Clamp)). FDA records list 7 510(k) clearances for Imris, Inc., from to . As of , FDA records show 3 recalls naming K103493.

Clearance record

Decision date
Received
(102 days to decision)
Product code
HBL Holder, Head, Neurosurgical (Skull Clamp)
Regulation
21 CFR 882.4460
Device class
Class II
Review panel
Neurology
Applicant
Imris, Inc. 16809 Briardale Rd., Rockville MD
510(k) summary
Summary PDF
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