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510(k) K844726

GAUZE SPONGE 4X4X12 PLY by Applied Medical — Product Code EFQ

K844726 is an FDA 510(k) premarket notification submitted by Applied Medical for the device "GAUZE SPONGE 4X4X12 PLY". The FDA issued a decision of Substantially Equivalent on April 1, 1985. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Applied Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1985
Date Received
December 4, 1984
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 Applied Medical

  • K202818 — Voyant Fine Fusion Device (EB230) (December 16, 2021)
  • K191866 — GelPOINT Mini Advanced Access Platform (April 29, 2020)
  • K122619 — EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET (October 2, 2012)
  • K070865 — EXPANDING VASCULAR SHEATH (October 23, 2007)
  • K003443 — SUCTION IRRIGATOR (February 1, 2001)
  • K002915 — FLEXIBLE OCCLUSION SYSTEM (January 8, 2001)
  • K915826 — BIO-POLAR FORCEPS (June 2, 1992)
  • K911462 — SURGICAL TROCAR (April 22, 1991)
  • K844675 — APPLIED GAUZE SPONGE 3X3X12 (April 1, 1985)
  • K844677 — APPLIED GAUZE SPONGE 2X2X12 (April 1, 1985)

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