Cleared Traditional

K980401 - FLEXIBLE FIBERSCOPES AND ACCESSORIES

K980401 is an FDA 510(k) clearance for FLEXIBLE FIBERSCOPES AND ACCESSORIES, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K980401 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
108d
Days
Class 2
Risk

K980401 is an FDA 510(k) clearance for the FLEXIBLE FIBERSCOPES AND ACCESSORIES. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on May 21, 1998 after a review of 108 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K980401

510(k) Number K980401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date May 21, 1998
Days to Decision 108 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
23d faster than avg
Panel avg: 131d · This submission: 108d
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 79
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K980401.
BAHO AUTOCLAVABLE CYSTOSCOPE
K992983 · Innovative Endoscopy Components, LLC · Oct 1999
MEDIFIX INC.
K992483 · Medifix, Inc. · Aug 1999
MEDIVISION CYSTOSCOPE
K982620 · Medivision Scope Service Center, Inc. · Sep 1998
NTECH CYSTOSCOPES
K980592 · N-Tech Endoscopy, Inc. · Apr 1998
FIEGERT ENDOTECH CYSTOSCOPE
K970892 · Fiegert, Inc. · May 1997
FLEXIBLE CYSTOSCOPE
K964037 · Applied Fiberoptics, Inc. · Feb 1997