Cleared Traditional

PHOENIX (K895855) - FDA 510(k) Clearance

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

K895855 · Medical and Scientific Enterprises, Inc. · Gastroenterology & Urology device
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Jan 1990
Decision
112d
Days
Class 2
Risk

K895855 is an FDA 510(k) clearance for the PHOENIX. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Medical and Scientific Enterprises, Inc. (Foxboro, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Medical and Scientific Enterprises, Inc. devices

Submission Details

510(k) Number K895855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date January 22, 1990
Days to Decision 112 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
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 73
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K895855.
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MICROVASIVE GOLD PROBE
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HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096 · Olympus Corp. · May 1985
DAVOL PAPILLITOME
K845015 · C.R. Bard, Inc. · Jan 1985