510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K953993Substantially Equivalent

Tympasnostomy Tube

Hampton Precision Products, Inc., Fenton MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953993 is the FDA 510(k) clearance record for TYMPASNOSTOMY TUBE, a class II device, cleared for Hampton Precision Products, Inc. on under FDA product code ETD (Tube, Tympanostomy). FDA records list one 510(k) clearance for Hampton Precision Products, Inc. As of , FDA records show no recalls naming K953993.

Clearance record

Decision date
Received
(19 days to decision)
Product code
ETD Tube, Tympanostomy
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Hampton Precision Products, Inc. 277 Haas Ln., Fenton MO
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