Company ยท US
Vision-Sciences, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2011. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 17 |
| 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 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2011 | K102733 | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR Vision-Sciences, Inc. | EOB |
| Feb 25, 2010 | K100125 | VISION SCIENCES FLEXIBLE ENT SCOPE Vision-Sciences, Inc. | EOB |
| Aug 3, 2009 | K091768 | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES Vision-Sciences, Inc. | EOQ |
| Dec 18, 2007 | K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. | FAJ |
| Nov 16, 2007 | K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. | HIH |
| Aug 29, 2007 | K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS Vision-Sciences, Inc. | EOX |
| Aug 29, 2007 | K072073 | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR Vision-Sciences, Inc. | EOB |
| Aug 2, 2007 | K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE Vision-Sciences, Inc. | EOX |
| Mar 16, 2006 | K053560 | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE Vision-Sciences, Inc. | FAJ |
| Apr 29, 2005 | K050972 | VISION-SCIENCES ENT-3000 SCOPE Vision-Sciences, Inc. | EOB |
| Apr 27, 2004 | K040984 | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE Vision-Sciences, Inc. | EOB |
| Apr 15, 2004 | K040215 | VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM Vision-Sciences, Inc. | FAJ |
| Aug 5, 2003 | K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOX |
| Jul 2, 2003 | K031790 | SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING Vision-Sciences, Inc. | EOB |
| Jan 9, 2003 | K024095 | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOB |
| Jul 15, 2002 | K012543 | VISION SCIENCES ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOB |
| May 24, 2002 | K021344 | B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM Vision-Sciences, Inc. | EOQ |
| Mar 31, 1999 | K990354 | ENDOSHEATH Vision-Sciences, Inc. | EOB |
| Jan 3, 1997 | K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. | FAM |
| Dec 23, 1996 | K963795 | VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH Vision-Sciences, Inc. | EOQ |
| Dec 16, 1996 | K964100 | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 Vision-Sciences, Inc. | FAM |
| Nov 21, 1996 | K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE Vision-Sciences, Inc. | FAM |
| Aug 5, 1996 | K950809 | VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES Vision-Sciences, Inc. | EOB |
| Jul 2, 1996 | K961591 | DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE Vision-Sciences, Inc. | EOB |
| Dec 22, 1995 | K942265 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH Vision-Sciences, Inc. | EOB |
| Feb 24, 1995 | K943715 | VISION SYSTEM UPPER G.I. EXDOSCOPE Vision-Sciences, Inc. | FDS |
| Feb 3, 1995 | K943895 | VISION SYSTEM COLONSCOPE Vision-Sciences, Inc. | FDF |
| Feb 14, 1994 | K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH Vision-Sciences, Inc. | FAM |
| Nov 22, 1993 | K933247 | PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS Vision-Sciences, Inc. | EOB |
| Jan 15, 1993 | K925421 | ENDOSHEATH Vision-Sciences, Inc. | EOB |
| Oct 28, 1992 | K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM Vision-Sciences, Inc. | FAM |
| Oct 6, 1992 | K921244 | DISPOSABLE PROTECTIVE SHEATH Vision-Sciences, Inc. | EOB |
| Sep 26, 1986 | K863367 | FORMALENS 2000 Vision-Sciences, Inc. | HQG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2012 | Vision-Sciences, Inc. Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [ Terminated |
EOB | K050972 K100125 |
| Jan 29, 2012 | Vision-Sciences, Inc. Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-305 Terminated |
EOB | K050972 K100125 |