510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912418Substantially Equivalent

Shikani Middle Meatal Antrostomy Vent Tube

Micromedics, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912418 is the FDA 510(k) clearance record for SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE, a class I device, cleared for Micromedics, Inc. on under FDA product code KAM (Cannula, Sinus). FDA records list 29 510(k) clearances for Micromedics, Inc., from to . As of , FDA records show no recalls naming K912418.

Clearance record

Decision date
Received
(203 days to decision)
Product code
KAM Cannula, Sinus
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Micromedics, Inc. 268 E. Lafayette Frontage, St. Paul MN
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