Cleared Traditional

K031141 - ASAP CYSTOSCOPE

Also marketed or referenced as:
ASAP LAPAROSCOPE ASAP LARYGOSCOPE ASAP OESOPHAGOSCOPE

K031141 is an FDA 510(k) clearance for ASAP CYSTOSCOPE, manufactured by Asap Endoscopic Products GmbH. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K031141 · Asap Endoscopic Products GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
81d
Days
Class 2
Risk

K031141 is an FDA 510(k) clearance for the ASAP CYSTOSCOPE. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Asap Endoscopic Products GmbH (Luebeck, DE). The FDA issued a Cleared decision on June 30, 2003 after a review of 81 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. 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 Asap Endoscopic Products GmbH devices

FDA 510(k) Submission Details - K031141

510(k) Number K031141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2003
Decision Date June 30, 2003
Days to Decision 81 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
50d faster than avg
Panel avg: 131d · This submission: 81d
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 K031141.
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
K040215 · Vision-Sciences, Inc. · Apr 2004
SOHNIKS
K033191 · Sohniks Endoscopy, Inc. · Mar 2004
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
K030960 · Acmi Corporation · Jul 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
UROSCOPE, ARTES MEDICAL, USA
K003988 · Artes Medical USA, Inc. · Sep 2001