Cleared Traditional

K870855 - UROSCAN

K870855 is an FDA 510(k) clearance for UROSCAN, manufactured by Endotherapeutics. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K870855 · Endotherapeutics · Gastroenterology & Urology device
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Jun 1987
Decision
98d
Days
Class 2
Risk

K870855 is an FDA 510(k) clearance for the UROSCAN. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Endotherapeutics (Menlo Park, US). The FDA issued a Cleared decision on June 9, 1987 after a review of 98 days - within the typical 510(k) review window.

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 Endotherapeutics devices

FDA 510(k) Submission Details - K870855

510(k) Number K870855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date June 09, 1987
Days to Decision 98 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
33d faster than avg
Panel avg: 131d · This submission: 98d
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 K870855.
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MODEL 4-SC FOUR WAY STOPCOCK
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MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR
K863167 · Life-Tech Intl., Inc. · Oct 1986
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
K863168 · Life-Tech Intl., Inc. · Oct 1986