Cleared Traditional

K003988 - UROSCOPE, ARTES MEDICAL, USA

K003988 is an FDA 510(k) clearance for UROSCOPE, manufactured by Artes Medical USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K003988 · Artes Medical USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
254d
Days
Class 2
Risk

K003988 is an FDA 510(k) clearance for the UROSCOPE, ARTES MEDICAL, USA. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Artes Medical USA, Inc. (San Diego, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 254 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Artes Medical USA, Inc. devices

FDA 510(k) Submission Details - K003988

510(k) Number K003988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date September 06, 2001
Days to Decision 254 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
123d slower than avg
Panel avg: 131d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAJ Device Classification - Class 2, Special Controls

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 88
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K003988.
ASAP CYSTOSCOPE
K031141 · Asap Endoscopic Products GmbH · Jun 2003
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc. · May 2002
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
K012929 · Circon Video · Nov 2001
CYSTOSCOPES
K003807 · Global Endoscopy, Inc. · Feb 2001
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
K993041 · The Olympus Optical Co. · Mar 2000
CORTEK CYSTOSCOPE
K000197 · Cortek Endoscopy, Inc. · Mar 2000