Cleared Traditional

K964780 - BARD DIRECTOR GUIDEWIRE (000560)

K964780 is an FDA 510(k) clearance for BARD DIRECTOR GUIDEWIRE (000560), manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K964780 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
91d
Days
Class 2
Risk

K964780 is an FDA 510(k) clearance for the BARD DIRECTOR GUIDEWIRE (000560). Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K964780

510(k) Number K964780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date February 26, 1997
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCY Device Classification - Class 2, Special Controls

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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 - OCY Endoscopic Guidewire, Gastroenterology-urology

All 35
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K964780.
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179 · Olympus Optical Co., Ltd. · Jul 2002
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
K990765 · Flexmedics · Mar 1999
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · Terumo Medical Corp. · Aug 1997
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
K964955 · Flexmedics · Feb 1997
BARD TIGER GUIDEWIRE MODEL 000540
K962178 · C.R. Bard, Inc. · Oct 1996
AMPLATZ SUPER STIFF GUIDEWIRE
K944959 · Boston Scientific Corp · Nov 1994