MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM— 510(k) K024095
Substantially EquivalentVision-Sciences, Inc.
FDA 510(k) clearance K024095 for MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM, Substantially Equivalent on 2003-01-09. Applicant: Vision-Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Vision-Sciences, Inc.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ayer, MA, US
Recent devices under product code EOB
view all- K261544 — Hydro Irrigation System
- K254133 — ENTity USB Videoscope System
- K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K241731 — Outlook Surgical Versa One System (8900139)
More clearances from Vision-Sciences, Inc.
view all- K102733 — VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
- K100125 — VISION SCIENCES FLEXIBLE ENT SCOPE
- K091768 — VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
- K072180 — VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
- K071127 — FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.