Cleared Special

K001270 - GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESE...

K001270 is an FDA 510(k) clearance for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESE..., manufactured by Gyrus Medical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FJL cleared through the Special 510(k) pathway after a 8-day FDA review.

K001270 · Gyrus Medical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
8d
Days
Class 2
Risk

K001270 is an FDA 510(k) clearance for the GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE. Classified as Resectoscope (product code FJL), Class II - Special Controls.

Submitted by Gyrus Medical , Ltd. (Cardiff, Wales, GB). The FDA issued a Cleared decision on April 28, 2000 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gyrus Medical , Ltd. devices

FDA 510(k) Submission Details - K001270

510(k) Number K001270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2000
Decision Date April 28, 2000
Days to Decision 8 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

FJL Device Classification - Class 2, Special Controls

Product Code FJL Resectoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FJL Resectoscope

All 17
Devices cleared under the same product code (FJL) and FDA review panel - the closest regulatory comparables to K001270.
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720 · Richard Wolf Medical Instruments Corp. · Mar 2007
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
K042523 · Richard Wolf Medical Instruments Corp. · Mar 2005
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
K041610 · Richard Wolf Medical Instruments Corp. · Aug 2004
KARL STORZ URETER RESECTOSCOPE
K960757 · KARL STORZ Endoscopy-America, Inc. · May 1996
RESECTOSCOPES
K954050 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS
K952574 · KARL STORZ Endoscopy-America, Inc. · Jul 1995