510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K953802Substantially Equivalent

Tympanostomy Tube

Bluff City Medical Technologies, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953802 is the FDA 510(k) clearance record for TYMPANOSTOMY TUBE, a class II device, cleared for Bluff City Medical Technologies, Inc. on under FDA product code ETD (Tube, Tympanostomy). FDA records list one 510(k) clearance for Bluff City Medical Technologies, Inc. As of , FDA records show no recalls naming K953802.

Clearance record

Decision date
Received
(78 days to decision)
Product code
ETD Tube, Tympanostomy
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bluff City Medical Technologies, Inc. 5295 E. Shelby Dr., Memphis 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