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FDA 510(k)

Sparrow Therapy System

K-Number: K201873 · 2021-01-02

ApplicantSpark Biomedical, Inc.
Decision Date2021-01-02
Product CodePZR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sparrow Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Spark Biomedical, Inc.. It received FDA 510(k) clearance on 2021-01-02 under 510(k) number K201873. The device is classified under product code PZR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sparrow Therapy System?

Sparrow Therapy System is a medical device that received FDA 510(k) clearance on 2021-01-02. The listed applicant is Spark Biomedical, Inc.. The 510(k) number is K201873.

When did Sparrow Therapy System receive FDA 510(k) clearance?

Sparrow Therapy System received FDA 510(k) clearance on 2021-01-02, under 510(k) number K201873.

Who is the listed applicant for Sparrow Therapy System?

The FDA 510(k) record lists Spark Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sparrow Therapy System?

The FDA product code for Sparrow Therapy System is PZR.

Related Clinical Trials

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Other records listing Spark Biomedical, Inc. 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.

K251246Sparrow AscentK230796Sparrow Ascent

Related Devices (Code: PZR)

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.

K251246Sparrow AscentSpark Biomedical, Inc.K233166NET Recovery Corp/NET DeviceNet RecoveryK230796Sparrow AscentSpark Biomedical, Inc.K221231Drug Relief v1Dyansys, Inc.K211971Drug Relief v1Dyansys, Inc.K173861Drug ReliefDyansys, 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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