RETINAL DETACHMENT IMPLANTS - Retinal Detachment Implants

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K963219 ↗

FDA Product Code

HQX

Models / Variants

Retinal Detachment Implants

Including Bans, Strips, Tires, Sleeves, Cords And Sponges

Device Class

Class II

Regulation

21 CFR Part 886.3340

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Snug Plug Punctum Plug

  Unclassified

  FDA 510(k) K061398 Active Cleared 11 Jul 2006

• Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges

  Class II

  FDA 510(k) K980816 Active Cleared 18 Sep 1998

• Punctum Plugs & Ready-Set Punctal Plugs

  Unclassified

  FDA 510(k) K964774 Active Cleared 20 Dec 1996

• Titanium Peg System

  Class II

  FDA 510(k) K980822 Active Cleared 9 Jul 1998

• Fci Mesh Wrapped Bioceramic Orbital Implant

  Class II

  FDA 510(k) K023400 Active Cleared 22 Aug 2003

• Self Retaining Bicanaliculus Intubation Set

  Unclassified

  FDA 510(k) K041869 Active Cleared 18 Nov 2004

See all devices from Fci Ophthalmics, Inc. →