510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945738Substantially Equivalent

Visiflex Ophthalmic Surgical Incise Drape

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

K945738 is the FDA 510(k) clearance record for VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE, a class II device, cleared for Visitec Co. on under FDA product code HMT (Drape, Patient, Ophthalmic). FDA records list 49 510(k) clearances for Visitec Co., from to . As of , FDA records show no recalls naming K945738.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HMT Drape, Patient, Ophthalmic
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Visitec Co. 7575 Commerce Ct., Sarasota FL
510(k) summary
Summary
Third party review
No

Clearances, product code HMT

Trailing 12 months

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

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