Cleared Traditional

K961248 - BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC...

K961248 is the FDA 510(k) clearance for BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFL) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K961248 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
57d
Days
Class 2
Risk

K961248 is an FDA 510(k) clearance for the BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE.... Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 28, 1996 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K961248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date May 28, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFL Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FFL Dislodger, Stone, Basket, Ureteral, Metal

All 22
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K961248.
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · Sterilmed, Inc. · Feb 2002
AMS FOREIGN BODY EXTRATOR
K972091 · American Medical Systems, Inc. · Aug 1997
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
K962387 · Olympus America, Inc. · Jul 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K955049 · Olympus America, Inc. · Dec 1995
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · Boston Scientific Corp · Sep 1994
STONE EXTRACTOR
K935721 · Boston Scientific Corp · Aug 1994