510(k) K961248

BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS by C.R. Bard, Inc. — Product Code FFL

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

Source: FDA 510(k) database entry for K961248. Report a data issue: hello@regdatalab.com.