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510(k) K921227

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE by Courtaulds Fibers, Inc. — Product Code NAB

K921227 is an FDA 510(k) premarket notification submitted by Courtaulds Fibers, Inc. for the device "TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE". The FDA issued a decision of Substantially Equivalent on May 29, 1992. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Courtaulds Fibers, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1992
Date Received
March 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

Other clearances by Courtaulds Fibers, Inc.

  • K972458 — LYOCELL WOUND DRESSING/SURGICAL SPONGE (September 19, 1997)
  • K932846 — TENCEL X-RAY DETECTABLE SPONGES/LAP PADS (December 9, 1993)

Other clearances for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • K931610 — OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (June 24, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K926072 — K-BAND AND K-CREPE (March 19, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)
  • K924650 — GAUZE SPONGES (January 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K923115 — CLINISORB (November 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (October 6, 1992)

FDA data resources