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510(k) K102943

CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 by Coreleader Biotech Co., Ltd. — Product Code FRO

K102943 is an FDA 510(k) premarket notification submitted by Coreleader Biotech Co., Ltd. for the device "CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050". The FDA issued a decision of Substantially Equivalent on April 12, 2011. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Coreleader Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2011
Date Received
October 4, 2010
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 Coreleader Biotech Co., Ltd.

  • K151204 — HEMO-Bandage (July 31, 2015)
  • K141382 — BIOS KING BIOCELLULOSE FILM (February 10, 2015)
  • K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (June 6, 2013)
  • K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW (September 23, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K102944 — CORELEADER HEMO-PAD MODEL CPII 02030 (September 7, 2011)
  • K102942 — CORELEADER ALGIPLASTER MODEL AP 050501 (June 22, 2011)
  • K102946 — CORELEADER COLLA-PAD MODEL CS 03030 (May 20, 2011)

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