510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861545Substantially Equivalent

Irrigation/aspiration Cannulas, Various Sizes

Rophae Lens Co., Inc., St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861545 is the FDA 510(k) clearance record for IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES, a class I device, cleared for Rophae Lens Co., Inc. on under FDA product code HMX (Cannula, Ophthalmic). FDA records list 2 510(k) clearances for Rophae Lens Co., Inc. As of , FDA records show no recalls naming K861545.

Clearance record

Decision date
Received
(34 days to decision)
Product code
HMX Cannula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Rophae Lens Co., Inc. 300 Bldg. W., Suite 208, St. Petersburg FL
Third party review
No

Clearances, product code HMX

Trailing 12 months

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

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