Cleared Traditional

Atteris No-Sting Skin Protectant

K160684 · Rochal Industries, LLC · General & Plastic Surgery
Jul 2016
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K160684 is an FDA 510(k) clearance for the Atteris No-Sting Skin Protectant, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Rochal Industries, LLC (San Antonio, US). The FDA issued a Cleared decision on July 26, 2016, 137 days after receiving the submission on March 11, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K160684 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2016
Decision Date July 26, 2016
Days to Decision 137 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KMF — Bandage, Liquid
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5090

Similar Devices — KMF Bandage, Liquid

All 221
TearRepair Liquid Skin Protectant
K241916 · Optmed, Inc. · Sep 2024
Rochal Bioshield Silicone Film
K182733 · Rochal Industries, LLC · Jun 2019
Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc. · Jan 2018
Cavilon Advanced High Endurance Skin Protectant
K153571 · 3M Healthcare · Aug 2016
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K131384 · Kericure, Inc. · Aug 2014
MARATHON NO STING LIQUID SKIN PROTECTANT
K133443 · Advanced Medical Solutions (Plymouth), Ltd. · Jul 2014