Home / 510(k) Clearances / K893123

510(k) K893123

ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES by Les Laboratorires Brothier, S.A. — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1990
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Les Laboratorires Brothier, S.A.

  • K041446 — NASALCEASE (July 1, 2004)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K922540 — WOUND DRESSING (August 24, 1992)
  • K905314 — ALGODERM ALGINATE WOUND DRESSING (February 19, 1991)

Other clearances for product code QSY

  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K253609 — TRAUMAGEL® 2.0 Hemostatic Gel (December 12, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K213413 — Hemostatic Dressing (September 1, 2023)