Cleared Traditional

K042780 - NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREA...

K042780 is an FDA 510(k) clearance for NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREA..., manufactured by Prosurg, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K042780 · Prosurg, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
120d
Days
Class 2
Risk

K042780 is an FDA 510(k) clearance for the NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Prosurg, Inc. (San Jose, US). The FDA issued a Cleared decision on February 3, 2005 after a review of 120 days - within the typical 510(k) review window.

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 Prosurg, Inc. devices

FDA 510(k) Submission Details - K042780

510(k) Number K042780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2004
Decision Date February 03, 2005
Days to Decision 120 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
10d faster than avg
Panel avg: 130d · This submission: 120d
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 63
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K042780.
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
K053560 · Vision-Sciences, Inc. · Mar 2006
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
K051176 · Richard Wolf Medical Instruments Corp. · Oct 2005
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K043022 · Stryker Endoscopy · Mar 2005
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
K040215 · Vision-Sciences, Inc. · Apr 2004
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc. · May 2002
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · Richard Wolf Medical Instruments Corp. · May 1998