Cleared Traditional

Sorbact Wound Dressing-Ribbon Gauze

K171225 · Abigo Medical AB · General & Plastic Surgery
Aug 2017
Decision
117d
Days
Risk

About This 510(k) Submission

K171225 is an FDA 510(k) clearance for the Sorbact Wound Dressing-Ribbon Gauze, a Dressing, Wound, Drug, submitted by Abigo Medical AB (Askim, SE). The FDA issued a Cleared decision on August 21, 2017, 117 days after receiving the submission on April 26, 2017. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K171225 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2017
Decision Date August 21, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

Similar Devices — FRO Dressing, Wound, Drug

All 698
Promogran Prisma? Collagen Matrix with ORC and Silver
K251999 · Solventum Germany GmbH · Mar 2026
LUOFUCON? Antimicrobial Wound Gel
K252028 · Huizhou Foryou Medical Co., Ltd. · Mar 2026
Redermax Antibacterial Wound Matrix
K251582 · Beijing Kreate Medical Co., Ltd. · Feb 2026
New Day Skin Spray
K252568 · Silk Holdings, Inc. · Jan 2026
SBC1 Cream
K250890 · Sioxmed, LLC · Jan 2026
revyve? Antimicrobial Skin and Wound Cleanser
K252759 · Kane Biotech, Inc. · Jan 2026