Cleared Traditional

AQUISEN (K952583) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952583 · Aquintel, Inc. · Gastroenterology & Urology device
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Aug 1995
Decision
80d
Days
Class 2
Risk

K952583 is an FDA 510(k) clearance for the AQUISEN. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Aquintel, Inc. (Longmont, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Aquintel, Inc. devices

Submission Details

510(k) Number K952583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date August 24, 1995
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJH System, Irrigation, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - LJH System, Irrigation, Urological

All 7
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K952583.
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K945210 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
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K940983 · KARL STORZ Endoscopy-America, Inc. · Sep 1994