510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925743Substantially Equivalent

Nasal Dorsum

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

K925743 is the FDA 510(k) clearance record for NASAL DORSUM, a class II device, cleared for Smith & Nephew Richards, Inc. on under FDA product code FZE (Prosthesis, Nose, Internal). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K925743.

Clearance record

Decision date
Received
(270 days to decision)
Product code
FZE Prosthesis, Nose, Internal
Regulation
21 CFR 878.3680
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Smith & Nephew Richards, Inc. 2925 Appling Rd., Bartlett TN
510(k) summary
Summary
Third party review
No

Clearances, product code FZE

Trailing 12 months

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

FDA records show no clearances under product code FZE in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260