510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834536Substantially Equivalent

Crystalcone Face Mask-Med-W/hookring

Warne Surgical Products, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834536 is the FDA 510(k) clearance record for CRYSTALCONE FACE MASK-MED-W/HOOKRING, a class I device, cleared for Warne Surgical Products, Ltd. on under FDA product code BSJ (Mask, Gas, Anesthetic). FDA records list 15 510(k) clearances for Warne Surgical Products, Ltd., from to . As of , FDA records show no recalls naming K834536.

Clearance record

Decision date
Received
(34 days to decision)
Product code
BSJ Mask, Gas, Anesthetic
Regulation
21 CFR 868.5550
Device class
Class I
Review panel
Anesthesiology
Applicant
Warne Surgical Products, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BSJ

Trailing 12 months

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

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