Vision-Sciences, Inc.
Medical device manufacturer in Orangeburg, NY.
33510(k) clearances
0PMA approvals
2recalls
Device types
- EOB Nasopharyngoscope (Flexible Or Rigid) 15
- FAM Sigmoidoscope And Accessories, Flexible/Rigid 5
- EOQ Bronchoscope (Flexible Or Rigid) 3
- EOX Esophagoscope (Flexible Or Rigid) 3
- FAJ Cystoscope And Accessories, Flexible/Rigid 3
- HQG Lens, Spectacle, Non-Custom (Prescription) 1
- FDF Colonoscope And Accessories, Flexible/Rigid 1
- FDS Gastroscope And Accessories, Flexible/Rigid 1
- HIH Hysteroscope (And Accessories) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102733 | Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences…EOB · Traditional | 05/18/2011SE |
| K100125 | Vision Sciences Flexible ENT ScopeEOB · Special | 02/25/2010SE |
| K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, DPU-5000/DPU-5050…EOQ · Traditional | 08/03/2009SE |
| K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemFAJ · Traditional | 12/18/2007SE |
| K071127 | Flexible Hysteroscope with Endosheath SystemHIH · Traditional | 11/16/2007SE |
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…EOX · Special | 08/29/2007SE |
| K072073 | Vision-Sciences ENT-5000 and ENT-5100 Video ENT Scope with Endosheath System…EOB · Special | 08/29/2007SE |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne ScopeEOX · Special | 08/02/2007SE |
| K053560 | Modified Endosheath System for Vsi Flexible CystoscopeFAJ · Special | 03/16/2006SE |
| K050972 | Vision-Sciences ENT-3000 ScopeEOB · Special | 04/29/2005SE |
| K040984 | Vision Sciences Model ENT-2000V Flexible Nasopharyngo-LaryngoscopeEOB · Special | 04/27/2004SE |
| K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-On Endosheath SystemFAJ · Traditional | 04/15/2004SE |
| K031786 | TNE-2000 Esophagoscope with Ecs-D Endosheath SystemEOX · Traditional | 08/05/2003SE |
| K031790 | Slide-On Endosheath System for Sensory TestingEOB · Traditional | 07/02/2003SE |
| K024095 | Modification to Vision Sciences Endosheath SystemEOB · Special | 01/09/2003SE |
| K012543 | Vision Sciences Endosheath SystemEOB · Traditional | 07/15/2002SE |
| K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath SystemEOQ · Special | 05/24/2002SE |
| K990354 | EndosheathEOB · Special | 03/31/1999SE |
| K964326 | Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath SystemFAM · Traditional | 01/03/1997SE |
| K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathEOQ · Traditional | 12/23/1996SE |
| K964100 | Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…FAM · Traditional | 12/16/1996SE |
| K963344 | Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeFAM · Traditional | 11/21/1996SE |
| K950809 | Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-LaryngoscopesEOB · Traditional | 08/05/1996SE |
| K961591 | Disposable Endosheath for E-F100 Flexible NasopharyngoscopeEOB · Traditional | 07/02/1996SE |
| K942265 | Flexible Nasopharyngo-Laryngoscope and EndosheathEOB · Traditional | 12/22/1995SE |
| K943715 | Vision System Upper G.I. ExdoscopeFDS · Traditional | 02/24/1995SE |
| K943895 | Vision System ColonscopeFDF · Traditional | 02/03/1995SE |
| K932843 | Flexible Video Sigmoidoscope System W/Disp. SheathFAM · Traditional | 02/14/1994SE |
| K933247 | Protective Sheath for Flexible Nasophary/LarygnosEOB · Traditional | 11/22/1993SE |
| K925421 | EndosheathEOB · Traditional | 01/15/1993SE |
| K921690 | Flexible Fiberoptic Sigmoidoscope SystemFAM · Traditional | 10/28/1992SE |
| K921244 | Disposable Protective SheathEOB · Traditional | 10/06/1992SE |
| K863367 | Formalens 2000HQG · Traditional | 09/26/1986SN |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0929-2012 | Product is a lithium ion battery sold as both a stand-alone accessory, and as part of…Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential… | 12/27/2011Terminated |
| Z-0928-2012 | Product is a lithium ion battery charger sold as both a stand-alone accessory, and as…Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential… | 12/27/2011Terminated |