Allevyn AG Dressing

510(k) Number

K063835 ↗

FDA product code

FRO

Device class

U

Advisory committee

Unknown

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code FRO (Dressing, Wound, Drug).

• INMAN MEDICAL OIL EMULSION DRESSING by Inman Medical Corp.
• MEPILEX AG ABSORBENT SILICONE-COATED DRESSING by Molnlycke Health Care, Inc.
• TT-102 by Tissue Technologies Holdings, LLC
• QUIKCLOT IPN928788 210 by TELEFLEX INCORPORATED
• AC5 Topical Gel by Arch Therapeutics, Inc.
• FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID by Ferris Mfg. Corp.
• PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION by Primary Care Solutions, Inc.
• HaloGUARD Protective Disc with CHG by Attwill Medical Solutions
• ADHEROL SEPP APPLICATOR by Medi-Flex Hospital Products, Inc.
• Dash-Topic Plus Cream by Founders Science Group, LLC

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

See all devices from Smith & Nephew, Inc. →