FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
K Number: K101657
·
Decision Oct 5, 2010
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
432
Review Days
116
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Basic Information
- Device Name
- RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
- K Number
- K101657
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- June 11, 2010
- Decision Date
- October 5, 2010
- Product Code
- KGE
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
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