Needle, Ophthalmic Suturing

FDA product code HNM · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic

2510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K844448Oms/Gonvers Retinal PerforatorHNM · Traditional Optical Micro Systems, Inc.08/21/1985SE
K780154Needleholder, Microvasular 5 1/2HNM · Traditional Edward Weck, Inc.03/17/1978SE

Recalls

RecallProductFirmInitiated
Z-0454-2008 BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #:…No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow Becton Dickinson and Company11/20/2007Terminated
Z-0453-2008 BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF…No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow. Becton Dickinson and Company11/20/2007Terminated