22MM Siteselect Breast Biopsy Device Model SSD022

Q: What is the product code of K011575?

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

FDA 510(k) K011575 · Imagyn Surgical

Substantially Equivalent

510(k) numberK011575

Submission

Device name: 22MM Siteselect Breast Biopsy Device Model SSD022
Applicant: Imagyn Surgical
Richland, MI, US
Received: May 22, 2001
Decision date: August 17, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code KNW

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K260517	Automatic Core Biopsy InstrumentKNW · Traditional	Zhejiang Curaway Medical Technology Co., Ltd.	08/28/2026SE
K262571	EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special	Bard Peripheral Vascular, Inc.	08/14/2026SE
K262792	Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special	Hologic, Inc.	08/12/2026SE
K260572	Marrow MarxmanKNW · Traditional	Medimetrix, LLC	08/04/2026SE
K261196	Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special	Promisemed Hangzhou Meditech Co., Ltd.	05/12/2026SE
K260365	Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional	Devicor Medical Products, Inc.	03/04/2026SE
K252795	ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional	Argon Medical Devices, Inc.	02/23/2026SE
K252681	EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional	Bard Peripheral Vascular, Inc.	12/12/2025SE
K252183	Resitu Slider 09 (RESL09)KNW · Traditional	Resitu Medical AB	09/24/2025SE
K243407	Forcyte Autograft Harvest KitKNW · Traditional	Forcyte Medical, LLC	07/29/2025SE

More from Forcyte Medical, LLC

510(k)	Device	Decision
K021174	Ecom Endotrachial Cardiac Output MonitorDSB · Traditional	04/29/2003SESU
K993936	15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM…KNW · Traditional	12/27/1999SE

Questions and answers

When was 22MM Siteselect Breast Biopsy Device Model SSD022 cleared by the FDA?

22MM Siteselect Breast Biopsy Device Model SSD022 (K011575) received a 510(k) decision of Substantially Equivalent on August 17, 2001, 87 days after the submission was received.

What is the product code of K011575?

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