Gyrus Acmi, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 25, 2024

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard)

K233275 · FGB

Gastroenterology & Urology · 178d

Cleared Jan 27, 2023

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE...

K221306 · GEX

Gastroenterology & Urology · 267d

Cleared Mar 08, 2018

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

K180086 · FGE

Gastroenterology & Urology · 55d

Cleared Feb 04, 2014

GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER

K132383 · LJE

Gastroenterology & Urology · 188d

Cleared Jun 20, 2012

GYRUS AMCI PK BUTTON ELECTRODE

K120567 · FAS

Gastroenterology & Urology · 114d

Cleared Oct 20, 2010

GYRUS ACMI BIOCOAG PROBE

K092571 · KNS

Gastroenterology & Urology · 425d

Cleared Feb 24, 2010

GYRUS ACMI PK BUTTON ELECTRODE

K093181 · FAS

Gastroenterology & Urology · 139d

Cleared Apr 20, 2009

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

K090814 · FAJ

Gastroenterology & Urology · 26d

Cleared Dec 13, 2007

GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM

K072594 · FGA

Gastroenterology & Urology · 90d