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510(k) K152970

Dynarex Xeroform Petrolatum Dressing by Dynarex Corporation — Product Code FRO

K152970 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "Dynarex Xeroform Petrolatum Dressing". The FDA issued a decision of Substantially Equivalent on October 3, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Dynarex Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2016
Date Received
October 8, 2015
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 Dynarex Corporation

  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K151575 — Dynarex Eye Cups (September 1, 2015)
  • K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC (June 7, 2011)
  • K102637 — DYNAREX ULTRASOUND GEL (February 16, 2011)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K082863 — DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING S (January 9, 2009)
  • K081569 — DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR US (September 12, 2008)

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