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
K853589Substantially Equivalent

Shah Self-Clearing Mastoid Suction Tube

Downs Surgical, Ltd., Wilmington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853589 is the FDA 510(k) clearance record for SHAH SELF-CLEARING MASTOID SUCTION TUBE, a class I device, cleared for Downs Surgical , Ltd. on under FDA product code JZF (Tube, Ear Suction). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K853589.

Clearance record

Decision date
Received
(118 days to decision)
Product code
JZF Tube, Ear Suction
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Downs Surgical , Ltd. 42 Industrial Way, Wilmington MA
Third party review
No

Clearances, product code JZF

Trailing 12 months

FDA records hold no clearances under product code JZF in the trailing twelve months.

FDA records show no clearances under product code JZF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260