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
K000801Substantially Equivalent

Pc Coated Fluoroplastic Vent Tubes

Gyrus Ent LLC, Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000801 is the FDA 510(k) clearance record for PC COATED FLUOROPLASTIC VENT TUBES, a class II device, cleared for Gyrus Ent LLC on under FDA product code ETD (Tube, Tympanostomy). FDA records list 28 510(k) clearances for Gyrus Ent LLC, from to . As of , FDA records show no recalls naming K000801.

Clearance record

Decision date
Received
(98 days to decision)
Product code
ETD Tube, Tympanostomy
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Gyrus Ent LLC 2925 Appling Rd., Bartlett TN
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 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