510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861369Substantially Equivalent

Incus/stapes Prosthesis

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

K861369 is the FDA 510(k) clearance record for INCUS/STAPES PROSTHESIS, a class II device, cleared for Richards Medical Co., Inc. on under FDA product code ETB (Prosthesis, Partial Ossicular Replacement). FDA records list 71 510(k) clearances for Richards Medical Co., Inc., from to . As of , FDA records show no recalls naming K861369.

Clearance record

Decision date
Received
(94 days to decision)
Product code
ETB Prosthesis, Partial Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Richards Medical Co., Inc. 1450 Brooks Rd., Memphis TN
Third party review
No

Clearances, product code ETB

Trailing 12 months
2 clearances under product code ETB in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260