Symphony

510(k) Number

K200413 ↗

FDA product code

KGN

FDA applicant

Aroa Biosurgery , Ltd.

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 KGN (Wound Dressing With Animal-Derived Material(S)).

• PriMatrix® 607-004-660 by TEI BIOSCIENCES INC.
• PriMatrix® 607-001-125 by TEI BIOSCIENCES INC.
• FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE by Johnson & Johnson Medical, Inc.
• PuraPly Micronized Wound Matrix (PuraPly MZ) by ORGANOGENESIS INC.
• PROCOLL by Innocoll Pharmaceuticals
• epi-ConneKt™ Wound Matrix by Mlm Biologics, Inc.
• MicroMatrix® Flex by ACELL, INC.
• ReyaGel (RG03 - MTP gel 3mL) by Fettech
• MEDLINE COLLAGEN WOUND DRESSING by MEDLINE INDUSTRIES, INC.
• InnovaMatrix by Triad Life Sciences, Inc.

• Endoform Dermal Template

  Unclassified

  FDA 510(k) K260669 Active Cleared 24 Jun 2026

• F10248-1012P

  Class III

  CE/MDD GUDID on market

• Endoform Reconstructive Template - PLGA

  Class II

  FDA 510(k) K250598 Active Cleared 3 Jun 2025

• Myriad Particles

  Unclassified

  FDA 510(k) K200502 Active Cleared 31 Mar 2021

See all devices from Aroa Biosurgery Ltd. →