Cleared Traditional

K861904 - HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE

K861904 is an FDA 510(k) clearance for HS-15M MICROWAVE SURGERY EQUIPMENT, manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K861904 · Cooper Lasersonics, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
153d
Days
Class 2
Risk

K861904 is an FDA 510(k) clearance for the HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 153 days - an extended review cycle.

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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K861904

510(k) Number K861904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1986
Decision Date October 16, 1986
Days to Decision 153 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 131d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

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 157
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K861904.
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · Cook Urological, Inc. · Aug 1988
THERMAL COAGULATOR
K870705 · Microvasive · Apr 1987
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413 · Cooper Lasersonics, Inc. · Dec 1986
ET/RT PAPILLOTOME
K860593 · Hobbs Medical, Inc. · Jul 1986
POLYPECTOMY SNARE
K862060 · Endovations · Jun 1986
CHALLENGER HOT BIOPSY FORCEPS
K860366 · Microvasive · Apr 1986