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510(k) K915809

VISITEC CANALICULAR STENT by Visitec Co. — Product Code LZU

K915809 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISITEC CANALICULAR STENT". The FDA issued a decision of Substantially Equivalent on February 24, 1992. The device falls under product code LZU (Plug, Punctum), a Class U device. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1992
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
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)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)

Other clearances for product code LZU

  • K241229 — Hello,eyes® BIO Plug (June 28, 2024)
  • K222164 — Visant Medical Canalicular Plug (December 23, 2022)
  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • K190210 — Tear Pool Dissolvable Punctum Plugs (October 24, 2019)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K150288 — PDO Absorbable Punctum Plug (August 28, 2015)
  • K140352 — VERAPLUG (November 13, 2014)
  • K140711 — COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLU (June 20, 2014)
  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)

FDA data resources