Device Atlas

Sparrow Therapy System

Q: What is the product code of K201873?

The FDA product code is PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal, a Class II (moderate risk) device regulated under 21 CFR 882.5896.

FDA 510(k) K201873 · Spark Biomedical, Inc.

Substantially Equivalent

510(k) numberK201873

Submission

Device name: Sparrow Therapy System
Applicant: Spark Biomedical, Inc.
Dallas, TX, US
Received: July 7, 2020
Decision date: January 2, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5896
Specialty: Neurology

Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.

Other 510(k)s with product code PZR

510(k)	Device	Applicant	Decision
K251246	Sparrow AscentPZR · Traditional	Spark Biomedical, Inc.	08/25/2025SE
K233166	NET Recovery Corp/NET DevicePZR · Traditional	Net Recovery	05/29/2024SE
K230796	Sparrow AscentPZR · Traditional	Spark Biomedical, Inc.	06/20/2023SE
K221231	Drug Relief v1PZR · Special	Dyansys, Inc.	06/06/2022SE
K211971	Drug Relief v1PZR · Traditional	Dyansys, Inc.	11/05/2021SE
K173861	Drug ReliefPZR · Traditional	Dyansys, Inc.	05/02/2018SE

More from Dyansys, Inc.

510(k)	Device	Decision
K251246	Sparrow AscentPZR · Traditional	08/25/2025SE
K230796	Sparrow AscentPZR · Traditional	06/20/2023SE

Questions and answers

When was Sparrow Therapy System cleared by the FDA?

Sparrow Therapy System (K201873) received a 510(k) decision of Substantially Equivalent on January 2, 2021, 179 days after the submission was received.

What is the product code of K201873?

The FDA product code is PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal, a Class II (moderate risk) device regulated under 21 CFR 882.5896.