Cleared Traditional

K963330 - URODYNAMIC ANALYSIS MODULE

K963330 is an FDA 510(k) clearance for URODYNAMIC ANALYSIS MODULE, manufactured by Synectics Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K963330 · Synectics Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
223d
Days
Class 2
Risk

K963330 is an FDA 510(k) clearance for the URODYNAMIC ANALYSIS MODULE. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Synectics Medical, Inc. (S-116 28 Stockholm, SE). The FDA issued a Cleared decision on April 3, 1997 after a review of 223 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Synectics Medical, Inc. devices

FDA 510(k) Submission Details - K963330

510(k) Number K963330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1996
Decision Date April 03, 1997
Days to Decision 223 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
92d slower than avg
Panel avg: 131d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 39
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K963330.
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
K113771 · Neurovision Medical Products, Inc. · Dec 2012
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
K974775 · Airtronic Services, Inc. · Feb 1998
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472 · Rusch Intl. · Aug 1996
SCHUSTER DISPOSABLE BALLOON PROBE
K931175 · Sandhill Scientific, Inc. · Apr 1994
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383 · Synectics-Dantec · Jun 1993