510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K261311Substantially Equivalent

Hyalomatrix

Anika Therapeutics, Inc., Beford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(134 days to decision)
Product code
QSZ Absorbable Synthetic Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
Anika Therapeutics, Inc. 32 Wiggins Ave., Beford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSZ

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