SPEEDYBELL
FDA 510(k) clearance K010735 · decided 2001-08-17
Clearance details
- K-number
- K010735
- Device name
- SPEEDYBELL
- Applicant
- Biopsybell S.A.S.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-12
- Decision date
- 2001-08-17
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- South Glastonbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.