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510(k) K884826

GAUZE SPONGE by Medical Action Industries, Inc. — Product Code EFQ

K884826 is an FDA 510(k) premarket notification submitted by Medical Action Industries, Inc. for the device "GAUZE SPONGE". The FDA issued a decision of Substantially Equivalent on December 22, 1988. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Medical Action Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1988
Date Received
November 18, 1988
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 Medical Action Industries, Inc.

  • K042526 — DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON S (April 25, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)
  • K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L (November 4, 2002)
  • K946019 — SURGICLA INSTRUMENT KIT (March 20, 1995)
  • K923846 — BURN DRESSING (September 11, 1992)
  • K810685 — SUTURE REMOVAL KIT (March 26, 1981)
  • K810184 — LAPAROTOMY SPONGE (February 4, 1981)

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