510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921195Substantially Equivalent

Nasal Septal Splint

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

K921195 is the FDA 510(k) clearance record for NASAL SEPTAL SPLINT, a class I device, cleared for Smith & Nephew Richards, Inc. on under FDA product code LYA (Splint, Intranasal Septal). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K921195.

Clearance record

Decision date
Received
(133 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew Richards, Inc. 1450 Brooks Rd., Memphis TN
510(k) summary
Summary
Third party review
No

Clearances, product code LYA

Trailing 12 months

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

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