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510(k) K973716

DUODERM EXTRA THIN CGF DRESSING by Convatec, A Bristol-Myers Squibb Co. — Product Code FRO

K973716 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "DUODERM EXTRA THIN CGF DRESSING". The FDA issued a decision of SN on December 17, 1997. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 17, 1997
Date Received
September 29, 1997
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 Convatec, A Bristol-Myers Squibb Co.

  • K032734 — CONVATEC FECAL MANAGEMENT SYSTEM (April 8, 2004)
  • K990368 — DUODERM HYDROACTIVE GEL WOUND DRESSING (March 26, 1999)
  • K982116 — AQUACEL HYDROFIBER WOUND DRESSING (September 8, 1998)
  • K973806 — DUODERM HYDROACTIVE GEL (December 29, 1997)
  • K973807 — DUODERM HYDROACTIVE PASTE (December 23, 1997)
  • K973717 — COMBIDERM ACD (December 17, 1997)
  • K954918 — COMBIDERM ACD (December 26, 1995)
  • K942941 — CONQUEST MALE CONTINENCE SYSTEM (March 17, 1995)
  • K940895 — EPIVIEW (November 22, 1994)

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