Vacuum Assisted Core Biopsy Device

FDA 510(k) K042290 · Suros Surgical Systems, Inc.

Substantially Equivalent

510(k) numberK042290

Submission

Device name
Vacuum Assisted Core Biopsy Device
Applicant
Suros Surgical Systems, Inc.
Indianapolis, IN, US
Received
August 24, 2004
Decision date
October 6, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KNW – Instrument, Biopsy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

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K260572Marrow MarxmanKNW · Traditional Medimetrix, LLC08/04/2026SE
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K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional Argon Medical Devices, Inc.02/23/2026SE
K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemKNW · Traditional Bard Peripheral Vascular, Inc.12/12/2025SE
K252183Resitu Slider 09 (RESL09)KNW · Traditional Resitu Medical AB09/24/2025SE
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More from Forcyte Medical, LLC

510(k)DeviceDecision
K062528Tissue Site Marking SystemNEU · Traditional 01/26/2007SE
K034021Vacuum Assisted Core Biopsy DeviceKNW · Traditional 09/08/2004SE

Questions and answers

When was Vacuum Assisted Core Biopsy Device cleared by the FDA?

Vacuum Assisted Core Biopsy Device (K042290) received a 510(k) decision of Substantially Equivalent on October 6, 2004, 43 days after the submission was received.

What is the product code of K042290?

The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.