FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
K Number: K072088
·
Decision Aug 29, 2007
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
33
Review Days
30
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Basic Information
- Device Name
- FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
- K Number
- K072088
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.4710
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vision-Sciences, Inc.
- Date Received
- July 30, 2007
- Decision Date
- August 29, 2007
- Product Code
- EOX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOX), ordered by most recent decision date.
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Other Clearances by Vision-Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102733 | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR | May 18, 2011 | Substantially Equivalent |
| K100125 | VISION SCIENCES FLEXIBLE ENT SCOPE | Feb 25, 2010 | Substantially Equivalent |
| K091768 | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES | Aug 3, 2009 | Substantially Equivalent |
| K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | Dec 18, 2007 | Substantially Equivalent |
| K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | Nov 16, 2007 | Substantially Equivalent |
| K072073 | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR | Aug 29, 2007 | Substantially Equivalent |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | Aug 2, 2007 | Substantially Equivalent |
| K053560 | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE | Mar 16, 2006 | Substantially Equivalent |
| K050972 | VISION-SCIENCES ENT-3000 SCOPE | Apr 29, 2005 | Substantially Equivalent |
| K040984 | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE | Apr 27, 2004 | Substantially Equivalent |