FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VS-100 VIDEO SIGMOIDOSCOPE
K Number: K970382
·
Decision Apr 17, 1997
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
111
Review Days
73
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Basic Information
- Device Name
- VS-100 VIDEO SIGMOIDOSCOPE
- K Number
- K970382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Welch Allyn, Inc.
- Date Received
- February 3, 1997
- Decision Date
- April 17, 1997
- 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.
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DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
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ES-3840, VIDEO SIGMOIDOSCOPE
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ES-3800, VIDEO SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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