Cleared Traditional

K992483 - MEDIFIX INC.

K992483 is an FDA 510(k) clearance for MEDIFIX INC., manufactured by Medifix, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K992483 · Medifix, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
35d
Days
Class 2
Risk

K992483 is an FDA 510(k) clearance for the MEDIFIX INC.. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Medifix, Inc. (Morton Grove, US). The FDA issued a Cleared decision on August 30, 1999 after a review of 35 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 Medifix, Inc. devices

FDA 510(k) Submission Details - K992483

510(k) Number K992483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date August 30, 1999
Days to Decision 35 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
96d faster than avg
Panel avg: 131d · This submission: 35d
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 74
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K992483.
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
K993041 · The Olympus Optical Co. · Mar 2000
AED CYSTOSCOPE
K993689 · National Advanced Endoscopy Devices, Inc. · Dec 1999
BAHO AUTOCLAVABLE CYSTOSCOPE
K992983 · Innovative Endoscopy Components, LLC · Oct 1999
MEDIVISION CYSTOSCOPE
K982620 · Medivision Scope Service Center, Inc. · Sep 1998
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · Richard Wolf Medical Instruments Corp. · May 1998
NTECH CYSTOSCOPES
K980592 · N-Tech Endoscopy, Inc. · Apr 1998