Cleared Special

ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL

K052044 · Acmi Corporation · Gastroenterology & Urology

Aug 2005

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K052044 is an FDA 510(k) clearance for the ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on August 16, 2005, 19 days after receiving the submission on July 28, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K052044 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	FGB — Ureteroscope And Accessories, Flexible/rigid
Device Class	Class II — 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).