Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022

K-Number: K011575 · 2001-08-17

ApplicantImagyn Surgical
Decision Date2001-08-17
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Surgical. It received FDA 510(k) clearance on 2001-08-17 under 510(k) number K011575. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022?

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 is a medical device that received FDA 510(k) clearance on 2001-08-17. The listed applicant is Imagyn Surgical. The 510(k) number is K011575.

When did 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 receive FDA 510(k) clearance?

22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 received FDA 510(k) clearance on 2001-08-17, under 510(k) number K011575.

Who is the listed applicant for 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022?

The FDA 510(k) record lists Imagyn Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022?

The FDA product code for 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 is KNW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Imagyn Surgical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021174ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITORK99393615MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE

Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑