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FDA 510(k)

SPEEDYBELL

K-Number: K010735 · 2001-08-17

ApplicantBiopsybell S.A.S.
Decision Date2001-08-17
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPEEDYBELL is the device name listed in this FDA 510(k) record. The listed applicant is Biopsybell S.A.S.. It received FDA 510(k) clearance on 2001-08-17 under 510(k) number K010735. 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 SPEEDYBELL?

SPEEDYBELL is a medical device that received FDA 510(k) clearance on 2001-08-17. The listed applicant is Biopsybell S.A.S.. The 510(k) number is K010735.

When did SPEEDYBELL receive FDA 510(k) clearance?

SPEEDYBELL received FDA 510(k) clearance on 2001-08-17, under 510(k) number K010735.

Who is the listed applicant for SPEEDYBELL?

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

What is the FDA product code for SPEEDYBELL?

The FDA product code for SPEEDYBELL 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 Biopsybell S.A.S. 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.

K011075EASYBELLK011104OSTEOBELL

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

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

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