510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823914Substantially Equivalent

Explorer Tip

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

K823914 is the FDA 510(k) clearance record for EXPLORER TIP, a class I device, cleared for Treace Medical, Inc. on under FDA product code EKB (Explorer, Operative). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K823914.

Clearance record

Decision date
Received
(24 days to decision)
Product code
EKB Explorer, Operative
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Treace Medical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EKB

Trailing 12 months

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

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