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510(k) K932846

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS by Courtaulds Fibers, Inc. — Product Code GDY

K932846 is an FDA 510(k) premarket notification submitted by Courtaulds Fibers, Inc. for the device "TENCEL X-RAY DETECTABLE SPONGES/LAP PADS". The FDA issued a decision of Substantially Equivalent on December 9, 1993. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Courtaulds Fibers, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1993
Date Received
June 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Courtaulds Fibers, Inc.

  • K972458 — LYOCELL WOUND DRESSING/SURGICAL SPONGE (September 19, 1997)
  • K921227 — TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE (May 29, 1992)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources