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FDA 510(k)

Sparrow Ascent

K-Number: K251246 · 2025-08-25

ApplicantSpark Biomedical, Inc.
Decision Date2025-08-25
Product CodePZR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sparrow Ascent 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 2025-08-25 under 510(k) number K251246. 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 Ascent?

Sparrow Ascent is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Spark Biomedical, Inc.. The 510(k) number is K251246.

When did Sparrow Ascent receive FDA 510(k) clearance?

Sparrow Ascent received FDA 510(k) clearance on 2025-08-25, under 510(k) number K251246.

Who is the listed applicant for Sparrow Ascent?

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 Ascent?

The FDA product code for Sparrow Ascent is PZR.

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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.

K230796Sparrow AscentK201873Sparrow Therapy System

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.

K233166NET Recovery Corp/NET DeviceNet RecoveryK230796Sparrow AscentSpark Biomedical, Inc.K221231Drug Relief v1Dyansys, Inc.K211971Drug Relief v1Dyansys, Inc.K201873Sparrow Therapy SystemSpark Biomedical, Inc.K173861Drug ReliefDyansys, 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.

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