Cleared Special

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -? Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope ? Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope ? Reverse (without pressure monitoring) (M0067941500)

K241598 · Boston Scientific Corporation · Gastroenterology & Urology

Jul 2024

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K241598 is an FDA 510(k) clearance for the LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -? Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope ? Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope ? Reverse (without pressure monitoring) (M0067941500), a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on July 1, 2024, 27 days after receiving the submission on June 4, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K241598 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2024
Decision Date	July 01, 2024
Days to Decision	27 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).