Cleared Traditional

K012587 - RF GENERATORS

K012587 is an FDA 510(k) clearance for RF GENERATORS, manufactured by Vidamed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K012587 · Vidamed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
123d
Days
Class 2
Risk

K012587 is an FDA 510(k) clearance for the RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDL.... Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Vidamed, Inc. (Fremont, US). The FDA issued a Cleared decision on December 11, 2001 after a review of 123 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 Vidamed, Inc. devices

FDA 510(k) Submission Details - K012587

510(k) Number K012587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date December 11, 2001
Days to Decision 123 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 130d · This submission: 123d
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 K012587.
WILSON-COOK TRI-TOME SELECT PLUS
K033203 · Wilson-Cook Medical, Inc. · Dec 2003
WILSON-COOK CYSTOTOME
K022595 · Wilson-Cook Medical, Inc. · Oct 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
K021266 · Ethicon Endo-Surgery, Inc. · Sep 2002
AUTOTOME RX MODEL # 4515, 4516
K013153 · Boston Scientific Corp · Oct 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · Arthrocare Corp. · Mar 2001
RAPID EXCHANGE TAPERTOME
K002802 · Boston Scientific Corp · Oct 2000