Cleared Traditional

K964067 - GORE IRRIGATION SET

K964067 is an FDA 510(k) clearance for GORE IRRIGATION SET, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K964067 · W.L. Gore & Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
238d
Days
Class 2
Risk

K964067 is an FDA 510(k) clearance for the GORE IRRIGATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 5, 1997 after a review of 238 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K964067

510(k) Number K964067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1996
Decision Date June 05, 1997
Days to Decision 238 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 129d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 798
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964067.
VENTED I.V. SET
K965027 · Jms Co., Ltd. · Jun 1997
CLAVE CONNECTOR
K970855 · Icu Medical, Inc. · Jun 1997
CONTINU-FLO SOLUTION SET
K971701 · Baxter Healthcare Corp · Jun 1997
TAMARYN I.V. FLOW REGULATOR EXTENSION SET
K971066 · Tamaryn Medical Systems, Inc. · Jun 1997
SAFE-CONNECT I.V. SET
K970909 · Faulding Medical Device Co. · May 1997
SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518
K971266 · Faulding Medical Device Co. · May 1997