Cleared Special

K090814 - MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

K090814 is an FDA 510(k) clearance for MODIFICATION TO GYRUS ACMI INVISIO ICN, manufactured by Gyrus Acmi, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Special 510(k) pathway after a 26-day FDA review.

K090814 · Gyrus Acmi, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
26d
Days
Class 2
Risk

K090814 is an FDA 510(k) clearance for the MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on April 20, 2009 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090814

510(k) Number K090814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date April 20, 2009
Days to Decision 26 days
Submission Type Special
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
105d faster than avg
Panel avg: 131d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 92
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K090814.
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
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K093725 · Canada Endoscope Corporation · Aug 2010
ENDO SMARTCAP
K093665 · Byrne Medical, Inc. · Dec 2009
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K072180 · Vision-Sciences, Inc. · Dec 2007
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
K060899 · Schoelly Imaging, Inc. · Mar 2007
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
K053560 · Vision-Sciences, Inc. · Mar 2006
K090814 · MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
Download PDF FDA Summary Gyrus Acmi, Inc.