510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800727Substantially Equivalent

Goode T-Tube, Biolite Coated Silicone/tu

Xomed, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800727 is the FDA 510(k) clearance record for GOODE T-TUBE, BIOLITE COATED SILICONE/TU, a class II device, cleared for Xomed, Inc. on under FDA product code ETD (Tube, Tympanostomy). FDA records list one 510(k) clearance for Xomed, Inc. As of , FDA records show no recalls naming K800727.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ETD Tube, Tympanostomy
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Xomed, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ETD

Trailing 12 months
1 clearance under product code ETD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ETD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260