Home / 510(k) Clearances / K850126

510(k) K850126

OIL EMULSION NON-ADHERING DRESSING by Absorbent Cotton Co., Inc. — Product Code FRO

K850126 is an FDA 510(k) premarket notification submitted by Absorbent Cotton Co., Inc. for the device "OIL EMULSION NON-ADHERING DRESSING". The FDA issued a decision of Substantially Equivalent on April 25, 1985. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Absorbent Cotton Co., Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1985
Date Received
January 14, 1985
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 Absorbent Cotton Co., Inc.

  • K883250 — STERI-CLENS WOUND CARE KIT (August 26, 1988)
  • K880613 — ACCO(R) FACE MASK (March 4, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K873523 — PLAIN DRY GAUZE (October 9, 1987)
  • K854740 — PRIMADERM (March 14, 1986)
  • K844095 — WET DRESSING WATER-STERILE (November 27, 1984)
  • K844096 — WET DRESSING SALINE-STERILE (November 19, 1984)
  • K781727 — CHANGE IN STERILIZATION PROCEDURE (December 4, 1978)

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