510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960477Substantially Equivalent

Ventilation Tubes

Smith & Nephew, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960477 is the FDA 510(k) clearance record for VENTILATION TUBES, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code ETD (Tube, Tympanostomy). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K960477.

Clearance record

Decision date
Received
(25 days to decision)
Product code
ETD Tube, Tympanostomy
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew, Inc. 555 13th St., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code ETD

Trailing 12 months
1 clearance under product code ETD 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 ETD, 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 20260
November 20260