Microverter Ureteral Access Sheath

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042877 ↗

FDA Product Code

KNY

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Accordion Stone Management Device Model AC281205 and AC3814510

  Class II

  FDA 510(k) K102887 Active Cleared 16 May 2011

• Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015

  Class II

  FDA 510(k) K082803 Active Cleared 13 Nov 2008

• Cystoglide Dilating Introducer Sheath

  Class II

  FDA 510(k) K052134 Active Cleared 22 Sep 2005

• Slip Urology Introducer Sheath

  Class II

  FDA 510(k) K040520 Active Cleared 20 May 2004

• Slip Urology Catheter

  Class II

  FDA 510(k) K040519 Active Cleared 20 May 2004

• What is the primary purpose of the Microverter Ureteral Access Sheath in clinical procedures?

  The Microverter Ureteral Access Sheath is designed as a urological introducer sheath to provide a controlled pathway for endoscopic instruments during urinary tract procedures. Its purpose is to reduce trauma to the ureter while improving precision and ease of access for instruments, making it suitable for minimally invasive urological interventions.

• Is the Microverter Ureteral Access Sheath intended for single-use or repeated use, and how is it supplied?

  The Microverter Ureteral Access Sheath is explicitly designed for single-use only. It is supplied sterile, pre-packaged, and includes an outer tube with a film membrane and a pusher tube to ensure compatibility with standard endoscopes and urological instruments.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  The Microverter Ureteral Access Sheath received FDA clearance through a 510(k) submission (K042877) under the Traditional 510(k) review pathway. The device was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its classification as a urological accessory under 21 CFR 876.5130 and its intended use in endoscopic urinary tract procedures.

• How does the design of the Microverter Ureteral Access Sheath support its use with standard urological instruments?

  The sheath is pre-loaded with a film membrane and includes a pusher tube, which ensures compatibility with standard endoscopes and urological instruments. This design minimizes trauma during insertion while providing a stable pathway for instruments, enhancing precision during procedures like ureteroscopy or stone removal.

• What medical specialties are most likely to use the Microverter Ureteral Access Sheath, and why?

  The Microverter Ureteral Access Sheath is primarily intended for use by urologists and gastroenterologists, as its classification and regulatory review reflect its application in endoscopic urinary tract procedures. The device’s design aligns with procedures requiring controlled access to the ureter, such as ureteral stone management or diagnostic evaluations.