510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830335Substantially Equivalent

Dorc Corneal Punch Block

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

K830335 is the FDA 510(k) clearance record for DORC CORNEAL PUNCH BLOCK, a class I device, cleared for Jedmed Instrument Co. on under FDA product code HNJ (Punch, Corneo-Scleral). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K830335.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HNJ Punch, Corneo-Scleral
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HNJ

Trailing 12 months

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

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