Cleared Traditional

K920451 - ENDOTEK ULTRA SYSTEM

K920451 is an FDA 510(k) clearance for ENDOTEK ULTRA SYSTEM, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K920451 · Surgitek · Gastroenterology & Urology device
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Sep 1992
Decision
226d
Days
Class 2
Risk

K920451 is an FDA 510(k) clearance for the ENDOTEK ULTRA SYSTEM. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 226 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 Surgitek devices

FDA 510(k) Submission Details - K920451

510(k) Number K920451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1992
Decision Date September 17, 1992
Days to Decision 226 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 131d · This submission: 226d
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 37
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K920451.
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
URETHRALPRESSURE PROFILE CATHETER
K915484 · Life-Tech Intl., Inc. · Feb 1992
URODYNAMIC CATHETER
K915443 · Cook Urological, Inc. · Feb 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · Biosearch Medical Products, Inc. · Feb 1992