510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950927Substantially Equivalent

Hapex Malleable Torp

Smith & Nephew Richards, Inc., Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950927 is the FDA 510(k) clearance record for HAPEX MALLEABLE TORP, a class II device, cleared for Smith & Nephew Richards, Inc. on under FDA product code ETA (Replacement, Ossicular Prosthesis, Total). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K950927.

Clearance record

Decision date
Received
(20 days to decision)
Product code
ETA Replacement, Ossicular Prosthesis, Total
Regulation
21 CFR 874.3495
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew Richards, Inc. 2925 Appling Rd., Bartlett TN
510(k) summary
Summary
Third party review
No

Clearances, product code ETA

Trailing 12 months
1 clearance under product code ETA in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ETA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260