510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870758Substantially Equivalent

Small Mastoid Retractor

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

K870758 is the FDA 510(k) clearance record for SMALL MASTOID RETRACTOR, a class I device, cleared for Treace Medical, Inc. on under FDA product code KAL (Retractor, Ent). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K870758.

Clearance record

Decision date
Received
(6 days to decision)
Product code
KAL Retractor, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Treace Medical, Inc. Suite 400, Memphis TN
Third party review
No

Clearances, product code KAL

Trailing 12 months

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

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