510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841359Substantially Equivalent

Fenestra Hook

Treace Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841359 is the FDA 510(k) clearance record for FENESTRA HOOK, a class II device, cleared for Treace Medical, Inc. on under FDA product code IYL (Collimator, Dermatological, Therapeutic X-Ray). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K841359.

Clearance record

Decision date
Received
(107 days to decision)
Product code
IYL Collimator, Dermatological, Therapeutic X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Treace Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IYL

Trailing 12 months

FDA records hold no clearances under product code IYL in the trailing twelve months.

FDA records show no clearances under product code IYL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260