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510(k) K983348

DYNAREX TRACHEOSTOMY SPONGE by Dynarex Corp. — Product Code EFQ

K983348 is an FDA 510(k) premarket notification submitted by Dynarex Corp. for the device "DYNAREX TRACHEOSTOMY SPONGE". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Dynarex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
September 23, 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 Dynarex Corp.

  • K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (December 22, 2005)
  • K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (November 9, 2005)
  • K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (October 17, 2002)
  • K012957 — TOWEL DRAPE, MODELS 4409, 4410 (March 6, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K991695 — DYNAREX NON-WOVEN SPONGE (July 15, 1999)
  • K991694 — DYNAREX DRAIN SPONGE (July 15, 1999)
  • K960388 — DYNAREX NON-WOVEN SPONGE (April 1, 1996)
  • K951660 — DYNAREX GAUZE SPONGE (May 9, 1995)
  • K933308 — DYNAREX GAUZE SPONGE OR PADS (December 22, 1993)

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)
  • 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