Cleared Traditional

K992362 - FLEXISCOPE IQ 101

K992362 is an FDA 510(k) clearance for FLEXISCOPE IQ 101, manufactured by Schoelly Fiberoptic GmbH. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K992362 · Schoelly Fiberoptic GmbH · Gastroenterology & Urology device
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Aug 1999
Decision
21d
Days
Class 2
Risk

K992362 is an FDA 510(k) clearance for the FLEXISCOPE IQ 101. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Schoelly Fiberoptic GmbH (Newton, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Schoelly Fiberoptic GmbH devices

FDA 510(k) Submission Details - K992362

510(k) Number K992362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1999
Decision Date August 05, 1999
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 62
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