# K961248: Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/Grasping Forceps

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 28, 1996 after 57 days
- Product code: FFL (Dislodger, Stone, Basket, Ureteral, Metal)
- Device class: 2
- Regulation: 21 CFR 876.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® Platinum Class™ 3 French Flat Wire Stone Basket: named in the summary without a submission number
- (no number) Bard® Platinum Class™ 3 French High-Torque Helical Stone Basket: named in the summary without a submission number
- (no number) Bard® Platinum Class™ 3 French Grasping Forceps: named in the summary without a submission number

## Indications for use
Bard® Platinum Class™ Ureteroscopic 3 French Flat Wire Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi. Bard® Platinum Class™ Ureteroscopic 3 French High-Torque Helical Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi. Bard® Platinum Class™ Ureteroscopic 3 French Grasping Forceps is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

Source page: https://510kreport.com/device/K961248
Methodology: https://510kreport.com/methodology