Cleared Traditional

K974637 - ELECTRODES/PROBES/DEVICES

K974637 is an FDA 510(k) clearance for ELECTRODES/PROBES/DEVICES, manufactured by Ximed/Prosure/Injectx. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K974637 · Ximed/Prosure/Injectx · Gastroenterology & Urology device
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Jan 1998
Decision
26d
Days
Class 2
Risk

K974637 is an FDA 510(k) clearance for the ELECTRODES/PROBES/DEVICES. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Ximed/Prosure/Injectx (San Jose, US). The FDA issued a Cleared decision on January 7, 1998 after a review of 26 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 Ximed/Prosure/Injectx devices

FDA 510(k) Submission Details - K974637

510(k) Number K974637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1997
Decision Date January 07, 1998
Days to Decision 26 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
104d faster than avg
Panel avg: 130d · This submission: 26d
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 29
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K974637.
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K031029 · Arthrocare Corp. · Jun 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543 · Arthrocare Corp. · Aug 2002
COAGULOOP
K991314 · American Medical Systems, Inc. · Jun 1999
AMS COAGULOOP RESECTION ELECTRODE
K971512 · American Medical Systems, Inc. · Jul 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · Arthrocare Corp. · May 1997
VAPOR-TECH SLED ELECTRODE
K970717 · Northgate Technologies, Inc. · May 1997