510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K935660Substantially Equivalent

Medicotex(trademark Application Pending)

Itochu International, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935660 is the FDA 510(k) clearance record for MEDICOTEX(TRADEMARK APPLICATION PENDING), a class II device, cleared for Itochu International, Inc. on under FDA product code FYA (Gown, Surgical). FDA records list one 510(k) clearance for Itochu International, Inc. As of , FDA records show no recalls naming K935660.

Clearance record

Decision date
Received
(101 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Itochu International, Inc. 335 Madison Ave., New York NY
510(k) summary
Summary
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260