510(k) K961248
K961248 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on May 28, 1996. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1996
- Date Received
- Apr 1, 1996
- 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
- 510(k) Exempt