Cleared Special

Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101

K231878 · STERIS Corporation · Gastroenterology & Urology

Jul 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K231878 is an FDA 510(k) clearance for the Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 25, 2023, 29 days after receiving the submission on June 26, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K231878 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2023
Decision Date	July 25, 2023
Days to Decision	29 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).