Cleared Traditional

K860571 - F.M. WEIST,KG (URODYNAMIC SYSTEMS)

K860571 is an FDA 510(k) clearance for F.M. WEIST, manufactured by F.M. Wiest USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K860571 · F.M. Wiest USA, Inc. · Gastroenterology & Urology device
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Mar 1986
Decision
32d
Days
Class 2
Risk

K860571 is an FDA 510(k) clearance for the F.M. WEIST,KG (URODYNAMIC SYSTEMS). Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by F.M. Wiest USA, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on March 18, 1986 after a review of 32 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.

View all F.M. Wiest USA, Inc. devices

FDA 510(k) Submission Details - K860571

510(k) Number K860571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1986
Decision Date March 18, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 131d · This submission: 32d
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 40
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K860571.
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