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510(k) K940716

OREX by Thantex Specialties, Inc. — Product Code EFQ

K940716 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "OREX". The FDA issued a decision of Substantially Equivalent on December 19, 1994. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1994
Date Received
February 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Thantex Specialties, Inc.

  • K970547 — ISOLYSER SDS SHARPS CONTAINER (July 18, 1997)
  • K961083 — OREX SURGEON'S VEST (August 23, 1996)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)
  • K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (June 16, 1995)
  • K945755 — OREX(R) O.R EQUIPMENT DRAPES (May 25, 1995)
  • K945223 — OREX ISOLATION GOWN (April 25, 1995)
  • K944827 — OREX SURGEON'S GOWN (February 28, 1995)
  • K944859 — OREX SURGICAL DRAPES (February 28, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K942228 — OREX O.R. TOWEL (December 20, 1994)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources