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
K922145Substantially Equivalent

Sinoject Maxillary Sinus Puncture & Irrigation Sys

Atos Medical AB, Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922145 is the FDA 510(k) clearance record for SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS, a class I device, cleared for Atos Medical AB on under FDA product code KAM (Cannula, Sinus). FDA records list 15 510(k) clearances for Atos Medical AB, from to . As of , FDA records show no recalls naming K922145.

Clearance record

Decision date
Received
(259 days to decision)
Product code
KAM Cannula, Sinus
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Atos Medical AB 9229 Cranford Dr., Potomac MD
510(k) summary
Statement
Third party review
No

Clearances, product code KAM

Trailing 12 months

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

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