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510(k) K940210

VISITEC EYE PAD by Visitec Co. — Product Code EFQ

K940210 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISITEC EYE PAD". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
January 14, 1994
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 Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K942234 — VISITEC PRECISE-POINT (July 12, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)
  • K923645 — VISITEC ASPIRATING SYRINGE (September 30, 1992)

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