510(k) K935721
K935721 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "STONE EXTRACTOR". The FDA issued a decision of Substantially Equivalent on August 22, 1994. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1994
- Date Received
- November 30, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Basket, Ureteral, Metal
- Device Class
- Class II
- Regulation Number
- 876.4680
- Review Panel
- GU
- Submission Type