510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934107Substantially Equivalent

Black Oval-Top Torp/porp

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

K934107 is the FDA 510(k) clearance record for BLACK OVAL-TOP TORP/PORP, 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 K934107.

Clearance record

Decision date
Received
(289 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
2 clearances under product code ETA in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ETA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260