EnCor EnCompass™ Breast Biopsy and Tissue Removal System

• • Ongoing Z-3275-2026 FDA Class II ·initiated 20 Aug 2026

  Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.

510(k) Number

K252681 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Peripheral Vascular Sheath Tunneler Sterilization Cassette

  Class II

  FDA 510(k) K042062 Active Cleared 30 Sep 2004

• True Dilatation Balloon Valvuloplasty Catheter, 20mm X 4.5 Cm, 22mm X 4.5cm, 24 Mm X 4.5cm, 26mm X 4.5cm

  Class II

  FDA 510(k) K133569 Active Cleared 20 Dec 2013

• UltraCor™ Twirl™ Breast Tissue Marker

  Class II

  FDA 510(k) K243642 Active Cleared 24 Mar 2025

• Rotarex Atherectomy System Open recall

  Class II

  FDA 510(k) K242757 Active Cleared 30 Jan 2025

• Venaflo II Vascular Graft

  Class II

  FDA 510(k) K052282 Active Cleared 20 Sep 2005

• Fluency Plus Tracheobronchial Stent Graft

  Class II

  FDA 510(k) K050832 Active Cleared 7 Jul 2005

See all devices from Bard Peripheral Vascular, Inc. →