510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883785Substantially Equivalent

Gy-Ro Safe

Gy-Ro Industry, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883785 is the FDA 510(k) clearance record for GY-RO SAFE, a class I device, cleared for Gy-Ro Industry, Inc. on under FDA product code HOG (Burr, Corneal, Battery-Powered). FDA records list one 510(k) clearance for Gy-Ro Industry, Inc. As of , FDA records show no recalls naming K883785.

Clearance record

Decision date
Received
(120 days to decision)
Product code
HOG Burr, Corneal, Battery-Powered
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Applicant
Gy-Ro Industry, Inc. Box 87794, Houston TX
Third party review
No

Clearances, product code HOG

Trailing 12 months

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

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