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510(k) K161212

Atteris Antimicrobial Skin Protectant by Rochal Industries, LLC — Product Code FRO

K161212 is an FDA 510(k) premarket notification submitted by Rochal Industries, LLC for the device "Atteris Antimicrobial Skin Protectant". The FDA issued a decision of Substantially Equivalent on September 30, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Rochal Industries, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2016
Date Received
April 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
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)
  • K160192 — Atteris Antimicrobial Skin & Wound Cleanser (July 28, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources