510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261725Substantially Equivalent

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Ironsides Medical, Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(118 days to decision)
Product code
SHL Ear, Nose, And Throat Image Analyzer
Regulation
21 CFR 874.4775
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Ironsides Medical, Inc. 1 Mifflin Pl., Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SHL

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