Home / 510(k) Clearances / K252681

510(k) K252681

EnCor EnCompass™ Breast Biopsy and Tissue Removal System by Bard Peripheral Vascular, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
August 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Bard Peripheral Vascular, Inc.

  • K260012 — UltraScore™ Focused Force PTA Balloon (February 4, 2026)
  • K250032 — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (July 10, 2025)
  • K250219 — Dorado™ PTA Balloon Dilatation Catheter (June 17, 2025)
  • K243642 — UltraCor™ Twirl™ Breast Tissue Marker (March 24, 2025)
  • K242757 — Rotarex Atherectomy System (January 30, 2025)
  • K241946 — PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Pe (December 6, 2024)
  • K232737 — PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp (December 8, 2023)
  • K221440 — Liverty™ TIPS Access Set (May 31, 2022)
  • K213896 — BD Trek Powered Bone Biopsy System (March 30, 2022)
  • K211933 — EleVation Breast Biopsy System (July 15, 2021)

Other clearances for product code KNW

  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De (February 23, 2026)
  • K252183 — Resitu Slider 09 (RESL09) (September 24, 2025)
  • K243407 — Forcyte Autograft Harvest Kit (July 29, 2025)
  • K244018 — Disposable Biopsy Needle (July 22, 2025)
  • K243296 — Disposable Biopsy Needle (July 11, 2025)
  • K250032 — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (July 10, 2025)
  • K243886 — ExpressCore Biopsy Device (April 29, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)
  • K242128 — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsv (February 27, 2025)