510(k) K101657
K101657 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40". The FDA issued a decision of Substantially Equivalent on October 5, 2010. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2010
- Date Received
- June 11, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Electric
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type