510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843487Substantially Equivalent

Visitec Ophthalmic Fluid Distrib- Set

Visitec Co., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843487 is the FDA 510(k) clearance record for VISITEC OPHTHALMIC FLUID DISTRIB- SET, a class II device, cleared for Visitec Co. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 49 510(k) clearances for Visitec Co., from to . As of , FDA records show no recalls naming K843487.

Clearance record

Decision date
Received
(188 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Visitec Co. 2043 Whitfield Park Dr., Sarasota FL
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260