RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
FDA 510(k) clearance K101657 · decided 2010-10-05
Clearance details
- K-number
- K101657
- 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
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2010-06-11
- Decision date
- 2010-10-05
- Days to decision
- 116 days
- Clearance type
- Abbreviated
- Product code
- KGE
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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