510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822368Substantially Equivalent

Calibrated Tissue Graft Press

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

K822368 is the FDA 510(k) clearance record for CALIBRATED TISSUE GRAFT PRESS, a class I device, cleared for Treace Medical, Inc. on under FDA product code JYW (Press, Vein). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K822368.

Clearance record

Decision date
Received
(34 days to decision)
Product code
JYW Press, Vein
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Treace Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JYW

Trailing 12 months

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

FDA records show no clearances under product code JYW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JYW, 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