Cleared Traditional

K970717 - VAPOR-TECH SLED ELECTRODE

K970717 is an FDA 510(k) clearance for VAPOR-TECH SLED ELECTRODE, manufactured by Northgate Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K970717 · Northgate Technologies, Inc. · Gastroenterology & Urology device
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May 1997
Decision
70d
Days
Class 2
Risk

K970717 is an FDA 510(k) clearance for the VAPOR-TECH SLED ELECTRODE. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on May 8, 1997 after a review of 70 days - a notably fast clearance 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: 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 Northgate Technologies, Inc. devices

FDA 510(k) Submission Details - K970717

510(k) Number K970717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1997
Decision Date May 08, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
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 - FAS Electrode, Electrosurgical, Active, Urological

All 44
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