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)

SpyGlass Discover Retrieval Basket

K-Number: K203322 · 2021-05-26

ApplicantBoston Scientific Corporation
Decision Date2021-05-26
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpyGlass Discover Retrieval Basket is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K203322. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpyGlass Discover Retrieval Basket?

SpyGlass Discover Retrieval Basket is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Boston Scientific Corporation. The 510(k) number is K203322.

When did SpyGlass Discover Retrieval Basket receive FDA 510(k) clearance?

SpyGlass Discover Retrieval Basket received FDA 510(k) clearance on 2021-05-26, under 510(k) number K203322.

Who is the listed applicant for SpyGlass Discover Retrieval Basket?

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

What is the FDA product code for SpyGlass Discover Retrieval Basket?

The FDA product code for SpyGlass Discover Retrieval Basket is LQR.

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.

NCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITINGNCT01550575Patient Retrospective Outcomes (PRO)RECRUITINGNCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITINGNCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITINGNCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITINGNCT02928497Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationTERMINATED

Other records listing Boston Scientific Corporation 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.

K262406EluPro Antibiotic-Eluting BioEnvelopePMA P150031Stimulator, electrical, implanted, for parkinsonian symptomsPMA P030017Stimulator, spinal-cord, totally implanted for pain reliefPMA P190006Implanted electrical device intended for treatment of fecal incontinencePMA P180046Stimulator, electrical, implantable, for incontinencePMA P180011Stent, superficial femoral artery, drug-eluting

View all 251 devices →

Related Devices (Code: LQR)

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.

K253056Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd.K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K201509Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd.

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.

↑