510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K934432Substantially Equivalent

Otoview Endoscopy System

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

K934432 is the FDA 510(k) clearance record for OTOVIEW ENDOSCOPY SYSTEM, a class I device, cleared for Smith & Nephew Richards, Inc. on under FDA product code EWA (Set, Audiometer Calibration). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K934432.

Clearance record

Decision date
Received
(224 days to decision)
Product code
EWA Set, Audiometer Calibration
Regulation
21 CFR 874.1080
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew Richards, Inc. 2929 Appling Rd., Bartlett TN
510(k) summary
Summary
Third party review
No

Clearances, product code EWA

Trailing 12 months

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

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