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510(k) K974316

HYDROFERA FEMORAL WICK by Hydrofera, LLC — Product Code EFQ

K974316 is an FDA 510(k) premarket notification submitted by Hydrofera, LLC for the device "HYDROFERA FEMORAL WICK". The FDA issued a decision of Substantially Equivalent on February 13, 1998. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Hydrofera, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1998
Date Received
November 17, 1997
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 Hydrofera, LLC

  • K190268 — Hydrofera Blue READY - Border (November 6, 2019)
  • K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (January 2, 2014)
  • K023138 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 17, 2003)
  • K013462 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 11, 2002)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K974313 — HYDROFERA SURGICAL SPEAR (March 2, 1998)

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