Home / 510(k) Clearances / K160684

510(k) K160684

Atteris No-Sting Skin Protectant by Rochal Industries, LLC — Product Code KMF

K160684 is an FDA 510(k) premarket notification submitted by Rochal Industries, LLC for the device "Atteris No-Sting Skin Protectant". The FDA issued a decision of Substantially Equivalent on July 26, 2016. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Rochal Industries, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2016
Date Received
March 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Rochal Industries, LLC

  • K192527 — Rochal Antimicrobial Wound Gel (February 7, 2020)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K161212 — Atteris Antimicrobial Skin Protectant (September 30, 2016)
  • K160192 — Atteris Antimicrobial Skin & Wound Cleanser (July 28, 2016)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)
  • K083913 — CHESSON LABS LIQUID BANDAGE (July 31, 2009)

FDA data resources