Cleared Traditional

K162017 - Ross Ru Wound Dressing Gel

K162017 · Biotd S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
273d
Days
-
Risk

K162017 is an FDA 510(k) clearance for the Ross Ru Wound Dressing Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Biotd S.A. (Heredia, CR). The FDA issued a Cleared decision on April 20, 2017 after a review of 273 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotd S.A. devices

FDA 510(k) Submission Details - K162017

510(k) Number K162017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2016
Decision Date April 20, 2017
Days to Decision 273 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 261
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K162017.
Microcyn Antimicrobial Hydrogel
K173896 · Sonoma Pharmaceuticals, Inc. · Apr 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
ACTICOAT Surgical Dressing
K153723 · Smith & Nephew Medical Limited · Sep 2016