510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914168Substantially Equivalent

Augustine Guide Kit with Gauze Sponge

Augustine Medical, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914168 is the FDA 510(k) clearance record for AUGUSTINE GUIDE KIT WITH GAUZE SPONGE, a class I device, cleared for Augustine Medical, Inc. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list 25 510(k) clearances for Augustine Medical, Inc., from to . As of , FDA records show no recalls naming K914168.

Clearance record

Decision date
Received
(20 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
Applicant
Augustine Medical, Inc. 10393 W. 70th St., Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code CCW

Trailing 12 months

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

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