Cleared Special

K052044 - ACMI AUTOCLAVABLE URETEROSCOPE

K052044 is an FDA 510(k) clearance for ACMI AUTOCLAVABLE URETEROSCOPE, manufactured by Acmi Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Special 510(k) pathway after a 19-day FDA review.

K052044 · Acmi Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
19d
Days
Class 2
Risk

K052044 is an FDA 510(k) clearance for the ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 19 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.

View all Acmi Corporation devices

FDA 510(k) Submission Details - K052044

510(k) Number K052044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2005
Decision Date August 16, 2005
Days to Decision 19 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 130d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

FGB Device Classification - Class 2, Special Controls

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic 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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 90
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K052044.
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · KARL STORZ Endoscopy-America, Inc. · Jun 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · KARL STORZ Endoscopy-America, Inc. · Nov 2013
STRYKER VIDEO URETEROSCOPE
K121112 · Stryker Endoscopy · Sep 2012
STRYKER URETEROSCOPE
K043021 · Stryker Endoscopy · Mar 2005
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · Olympus Winter & Ibe GmbH · Jan 2004
STRYKER FLEXIBLE URETEROSCOPE
K031278 · Stryker Endoscopy · Oct 2003