Sanarus Centrica Core Tissue Biopsy System

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

510(k) Number

K021137 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Modification to:sanarus Visica Treatment System, Models VS2000

  Class II

  FDA 510(k) K052861 Active Cleared 15 Nov 2005

• V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600

  Class II

  FDA 510(k) K062896 Active Cleared 3 Jan 2007

• Sanarus Centrica II Rotational Core Biopsy System

  Class II

  FDA 510(k) K032506 Active Cleared 9 Oct 2003

• Modification to Sanarus Centrica Core Tissue Biopsy

  Class II

  FDA 510(k) K022879 Active Cleared 23 Sep 2002

• Modification to Sanarus Visica Treatment System

  Class II

  FDA 510(k) K021211 Active Cleared 26 Jun 2002

• Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012

  Class II

  FDA 510(k) K080171 Active Cleared 6 Mar 2008

See all devices from Sanarus Medical, Inc. →

• What is the Sanarus Centrica Core Tissue Biopsy System used for?

  The Sanarus Centrica Core Tissue Biopsy System is an instrument designed for obtaining core biopsy samples in gastroenterology and urology procedures. It uses cold technology to perform tissue biopsies and consists of a sticking needle, cutting cannula, control unit, and specimen container.

• Is the Sanarus Centrica Core Tissue Biopsy System single-use or reusable?

  The Sanarus Centrica Core Tissue Biopsy System is supplied as a single-use system, meaning it is intended for one procedure only and should not be reused on multiple patients to ensure safety and effectiveness.

• What are the storage requirements for the Sanarus Centrica Core Tissue Biopsy System?

  The Sanarus Centrica Core Tissue Biopsy System is stored at room temperature, making it convenient for clinical settings without requiring special refrigeration or temperature-controlled storage conditions.

• What regulatory clearance does the Sanarus Centrica Core Tissue Biopsy System have?

  The Sanarus Centrica Core Tissue Biopsy System has FDA 510(k) clearance with the product code KNW. It is classified as Class II and received traditional clearance in 2002, indicating it meets the safety and effectiveness requirements for its intended use.