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510(k) K983016

GAUZE, SPONGES, CAT # 11-003 by Vitalcare Group, Inc. — Product Code EFQ

K983016 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "GAUZE, SPONGES, CAT # 11-003". The FDA issued a decision of Substantially Equivalent on February 12, 1999. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1999
Date Received
August 28, 1998
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 Vitalcare Group, Inc.

  • K060109 — OMI RETRACTABLE SAFETY SYRINGE (May 5, 2006)
  • K050906 — VITALCARE I.V. ADMINISTRATION SET (August 23, 2005)
  • K040916 — VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE (May 4, 2005)
  • K031748 — VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES (August 27, 2003)
  • K992289 — VINYL POWDERED EXAM GLOVE / CAT.# 15-020 (August 4, 1999)
  • K983716 — VITALCARE DISPOSABLE VAGINAL SPECULUM (December 23, 1998)
  • K982901 — LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED (December 21, 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)
  • 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)
  • K974316 — HYDROFERA FEMORAL WICK (February 13, 1998)

FDA data resources