510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791763Substantially Equivalent

(Micro-Keratron, Micro Duct Trephine)

Intl. Ophthalmic Industries Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791763 is the FDA 510(k) clearance record for (MICRO-KERATRON, MICRO DUCT TREPHINE), a class I device, cleared for Intl. Ophthalmic Industries Corp. on under FDA product code HRG (Engine, Trephine, Accessories, Ac-Powered). FDA records list 6 510(k) clearances for Intl. Ophthalmic Industries Corp., from to . As of , FDA records show no recalls naming K791763.

Clearance record

Decision date
Received
(61 days to decision)
Product code
HRG Engine, Trephine, Accessories, Ac-Powered
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Applicant
Intl. Ophthalmic Industries Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HRG

Trailing 12 months

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

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