FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
K Number: K963344
·
Decision Nov 21, 1996
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
33
Review Days
87
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Basic Information
- Device Name
- DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
- K Number
- K963344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vision-Sciences, Inc.
- Date Received
- August 26, 1996
- Decision Date
- November 21, 1996
- Product Code
- FAM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAM), ordered by most recent decision date.
ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VS-100 VIDEO SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ES-3840, VIDEO SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ES-3800, VIDEO SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | Aug 29, 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 |