510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904918Substantially Equivalent

Belscope Laryngoscope

Avulunga Pty., Ltd., N.S.W., Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904918 is the FDA 510(k) clearance record for BELSCOPE LARYNGOSCOPE, a class I device, cleared for Avulunga Pty. , Ltd. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list one 510(k) clearance for Avulunga Pty. , Ltd. As of , FDA records show no recalls naming K904918.

Clearance record

Decision date
Received
(264 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
Applicant
Avulunga Pty. , Ltd. P.O. Box 475, N.S.W., Australia, AU
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