Cleared Traditional

K812213 - AUTOMATED ELECTROCAUTERY SYSTEM

K812213 is an FDA 510(k) clearance for AUTOMATED ELECTROCAUTERY SYSTEM, manufactured by University of Washington. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K812213 · University of Washington · Gastroenterology & Urology device
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Nov 1981
Decision
92d
Days
Class 2
Risk

K812213 is an FDA 510(k) clearance for the AUTOMATED ELECTROCAUTERY SYSTEM. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by University of Washington (Walker, US). The FDA issued a Cleared decision on November 5, 1981 after a review of 92 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 University of Washington devices

FDA 510(k) Submission Details - K812213

510(k) Number K812213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1981
Decision Date November 05, 1981
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
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 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K812213.
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE
K851964 · Wilson-Cook Medical, Inc. · Jun 1985
HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096 · Olympus Corp. · May 1985
DAVOL PAPILLITOME
K845015 · C.R. Bard, Inc. · Jan 1985
POLYPECTOMY SNARE
K810336 · Medi-Tech, Inc. · Mar 1981
PAPILLOTOME PRODUCT
K802444 · Mill-Rose Laboratory · Oct 1980
CONCEPT SUCTION COAGULATOR
K800321 · Concept, Inc. · Feb 1980