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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 a medical device manufactured by Spark Biomedical, Inc.. It received FDA 510(k) clearance on 2025-08-25 under approval 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. It is manufactured by Spark Biomedical, Inc.. The 510(k) number is K251246.

When was Sparrow Ascent approved by the FDA?

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

What company makes Sparrow Ascent?

Sparrow Ascent is manufactured by Spark Biomedical, Inc..

What is the FDA product code for Sparrow Ascent?

The FDA product code for Sparrow Ascent is PZR.

Related Clinical Trials

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Other Devices by Spark Biomedical, Inc.

K201873Sparrow Therapy System K230796Sparrow Ascent

Related Devices (Code: PZR)

DEN170018NSS-2 SystemInnovative Health Solutions (Ihs), Inc. K173861Drug ReliefDyansys, Inc. K211971Drug Relief v1Dyansys, Inc. K201873Sparrow Therapy SystemSpark Biomedical, Inc. K221231Drug Relief v1Dyansys, Inc. K230796Sparrow AscentSpark Biomedical, 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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