510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834356Substantially Equivalent

Eye Sponge or Spear

JEDMED Instrument Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834356 is the FDA 510(k) clearance record for EYE SPONGE OR SPEAR, a class II device, cleared for Jedmed Instrument Co. on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K834356.

Clearance record

Decision date
Received
(94 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HOZ

Trailing 12 months

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

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