Cleared Traditional

K980592 - NTECH CYSTOSCOPES

K980592 is an FDA 510(k) clearance for NTECH CYSTOSCOPES, manufactured by N-Tech Endoscopy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K980592 · N-Tech Endoscopy, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
70d
Days
Class 2
Risk

K980592 is an FDA 510(k) clearance for the NTECH CYSTOSCOPES. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by N-Tech Endoscopy, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 28, 1998 after a review of 70 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 N-Tech Endoscopy, Inc. devices

FDA 510(k) Submission Details - K980592

510(k) Number K980592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date April 28, 1998
Days to Decision 70 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
61d faster than avg
Panel avg: 131d · This submission: 70d
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 83
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K980592.
MEDIFIX INC.
K992483 · Medifix, Inc. · Aug 1999
MEDIVISION CYSTOSCOPE
K982620 · Medivision Scope Service Center, Inc. · Sep 1998
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · Richard Wolf Medical Instruments Corp. · May 1998
FIEGERT ENDOTECH CYSTOSCOPE
K970892 · Fiegert, Inc. · May 1997
FLEXIBLE CYSTOSCOPE
K964037 · Applied Fiberoptics, Inc. · Feb 1997
CYSTOSCOPE 0/15/30/70 DEGREES
K960872 · Pollux Endoscopy, Inc. · May 1996