510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043491Substantially Equivalent

Enfanttm

Diopsys Inc, Pine Brook NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043491 is the FDA 510(k) clearance record for ENFANTTM, a class II device, cleared for Diopsys, Inc. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list 2 510(k) clearances for Diopsys, Inc., from to . As of , FDA records show one recall naming K043491.

Clearance record

Decision date
Received
(89 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Diopsys, Inc. 16 Chapin Rd. Suite 911, Pine Brook NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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