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510(k) K963724

GAUZE SPONGE, NON X-RAY DETECTABLE by Grand Medical Products — Product Code EFQ

K963724 is an FDA 510(k) premarket notification submitted by Grand Medical Products for the device "GAUZE SPONGE, NON X-RAY DETECTABLE". The FDA issued a decision of SN on November 29, 1996. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Grand Medical Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 29, 1996
Date Received
September 16, 1996
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 Grand Medical Products

  • K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
  • K963721 — SKIN SCRUB TRAY (November 27, 1996)
  • K963714 — GRAND MEDICAL SUTURE REMOVAL KIT (November 27, 1996)
  • K963723 — LACERATION TRAY (November 27, 1996)
  • K963720 — TRACHEOSTOMY KIT (November 27, 1996)
  • K963715 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (November 27, 1996)
  • K963722 — IV START KIT (November 27, 1996)

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