510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842647Substantially Equivalent

Cataract Tray

DeRoyal Industries, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842647 is the FDA 510(k) clearance record for CATARACT TRAY, a class I device, cleared for Deroyal Industries, Inc. on under FDA product code HNN (Knife, Ophthalmic). FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K842647.

Clearance record

Decision date
Received
(303 days to decision)
Product code
HNN Knife, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
Third party review
No

Clearances, product code HNN

Trailing 12 months

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

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