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510(k) K970266

KENDALL HYDROPHILIC POWDER WOUND DRESSING by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code KGN

K970266 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "KENDALL HYDROPHILIC POWDER WOUND DRESSING". The FDA issued a decision of SN on April 23, 1997. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Kendall Healthcare Products Co. Div.Of Tyco Health has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 23, 1997
Date Received
January 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

  • K973763 — KENDALL CURITY IODOFORM PACKING STRIP (December 31, 1997)
  • K973511 — KENDALL CURITY PETROLATUM GAUZE (December 16, 1997)
  • K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (December 15, 1997)
  • K973619 — KENDALL CURITY NON-ADHERING DRESSING (December 10, 1997)
  • K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (December 4, 1997)
  • K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (November 7, 1997)
  • K963446 — KENDALL DUAL LUMEN CATHETER (March 18, 1997)
  • K964899 — KENDALL CURITY URETERAL CATHETER (February 7, 1997)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE (July 31, 1996)

Other clearances for product code KGN

  • K260596 — Collagen Wound Powder (July 2, 2026)
  • K260669 — Endoform Dermal Template (June 24, 2026)
  • K253521 — ECMT-100 WMD (June 18, 2026)
  • K253204 — Catalyze (June 5, 2026)
  • K253974 — Roosin Collagen Dressing (June 3, 2026)
  • K254034 — Roosin Collagen Powder (June 3, 2026)
  • K261224 — MatriDerm (May 14, 2026)
  • K260532 — Derma-Gide (March 19, 2026)
  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)

FDA data resources