Ophta Sil (R), Lachrymal Intubation Sets

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K911109 ↗

FDA Product Code

OKS

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Ophta Sil (R), Punctal Plugs and Inserters

  Unclassified

  FDA 510(k) K911108 Active Cleared 13 May 1991

• Digital Ultrasound Imaging System Dub 20

  Class II

  FDA 510(k) K896029 Active Cleared 12 Jan 1990

• Ophta Sil {self-Threading Monoka (Ritleng Type)}

  Unclassified

  FDA 510(k) K950569 Active Cleared 14 Mar 1995

• Ritleng Bican.lacr.sets/Self Thread. Monokas(Chg.in Ster.)

  Unclassified

  FDA 510(k) K955671 Active Cleared 6 Mar 1996

• Ophta Sil(R), Enulceation/Evisceration Implants

  Class II

  FDA 510(k) K911110 Active Cleared 18 Jun 1991

• Ophta Sil (Ritleng Probe and Lacrimal Intubation Set)

  Unclassified

  FDA 510(k) K940508 Active Cleared 4 May 1994

See all devices from G.W.B. Intl., Ltd. →