510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250420Substantially Equivalent

Helios Dura Regeneration Matrix

Helios Biomedical Inc., Weston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250420 is the FDA 510(k) clearance record for Helios Dura Regeneration Matrix, a class II device, cleared for Helios Biomedical, Inc. on under FDA product code GXQ (Dura Substitute). FDA records list 2 510(k) clearances for Helios Biomedical, Inc., from to . As of , FDA records show no recalls naming K250420.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GXQ Dura Substitute
Regulation
21 CFR 882.5910
Device class
Class II
Review panel
Neurology
Applicant
Helios Biomedical, Inc. 11 Dellbrook Rd., Weston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXQ

Trailing 12 months
1 clearance under product code GXQ 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 GXQ, 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