VISION SYSTEM UPPER G.I. EXDOSCOPE— 510(k) K943715
Substantially EquivalentVision-Sciences, Inc.
FDA 510(k) clearance K943715 for VISION SYSTEM UPPER G.I. EXDOSCOPE, Substantially Equivalent on 1995-02-24. Applicant: Vision-Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Vision-Sciences, Inc.
- Product code
- Code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick, MA, US
Recent devices under product code FDS
view allMore 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 FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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.