FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEEDYBELL
K Number: K010735
·
Decision Aug 17, 2001
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
3
Review Days
158
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Basic Information
- Device Name
- SPEEDYBELL
- K Number
- K010735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biopsybell S.A.S.
- Date Received
- March 12, 2001
- Decision Date
- August 17, 2001
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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