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
K072334Substantially Equivalent

Sialo Drain

Sialo Technology, Ltd., Kfar Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072334 is the FDA 510(k) clearance record for SIALO DRAIN, a class I device, cleared for Sialo Technology, Ltd. on under FDA product code OAJ (Catheter, Drainage, Intraoral/Extraoral). FDA's definition for product code OAJ reads: "To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the...". FDA records list 4 510(k) clearances for Sialo Technology, Ltd., from to . As of , FDA records show no recalls naming K072334.

Clearance record

Decision date
Received
(333 days to decision)
Product code
OAJ Catheter, Drainage, Intraoral/Extraoral
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sialo Technology, Ltd. 20 Hata'As St., Kfar Saba, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAJ

Trailing 12 months

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

FDA records show no clearances under product code OAJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OAJ, 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