Cleared Traditional

K790519 - ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

K790519 is an FDA 510(k) clearance for ULTRALITE UROSYSTEM, manufactured by American Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K790519 · American Medical Systems, Inc. · Gastroenterology & Urology device
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May 1979
Decision
59d
Days
Class 2
Risk

K790519 is an FDA 510(k) clearance for the ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K790519

510(k) Number K790519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1979
Decision Date May 14, 1979
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 131d · This submission: 59d
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 83
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K790519.
BROWNE MODEL UA-6
K792094 · Browne Corp. · Dec 1979
BROWNE MODEL UD-4DE
K790478 · Browne Corp. · Jun 1979
BROWNE MODEL CF-1 AND CF-1G
K790754 · Browne Corp. · Jun 1979
UROFLOW-CYSTOMETER SYSTEM
K771850 · Richard Wolf Medical Instruments Corp. · Oct 1977
CATHETER, URETHRAL PRESSURE, UPE-10 & 12
K770579 · Life-Tech Instruments, Inc. · May 1977
K790519 · ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
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