Neuromonitoring Kit

Q: What is the product code of K161893?

The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.

FDA 510(k) K161893 · SI-BONE, Inc.

Substantially Equivalent

510(k) numberK161893

Submission

Device name: Neuromonitoring Kit
Applicant: SI-BONE, Inc.
San Jose, CA, US
Received: July 11, 2016
Decision date: October 18, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PDQ – Neurosurgical Nerve Locator
Device class: Class II (moderate risk)
Regulation: 21 CFR 874.1820
Specialty: Ear, Nose, Throat

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Other 510(k)s with product code PDQ

510(k)	Device	Applicant	Decision
K260992	iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…PDQ · Traditional	Neuralytix	06/25/2026SE
K253580	Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…PDQ · Traditional	Tedan Surgical Innovations	04/26/2026SE
K243636	Neuralytix iD3 System (NTX-9001)PDQ · Traditional	Neuralytix, LLC	06/26/2025SE
K223438	TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQ · Traditional	Medos International SARL	02/10/2023SE
K221821	ATEC IOM Accessory InstrumentsPDQ · Traditional	Alphatec Spine, Inc.	09/23/2022SE
K220160	PediGuard ThreadedPDQ · Traditional	Spineguard S.A.	03/31/2022SE
K203684	Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional	Magstim Company, Ltd.	03/17/2021SE
K201454	DSG Connect TechnologyPDQ · Traditional	Spineguard S.A.	02/10/2021SE
K191723	ATEC IOM Accessory InstrumentsPDQ · Traditional	Alphatec Spine, Inc.	10/18/2019SE
K190163	ALARA Neuro Access KitPDQ · Traditional	SurGenTec, LLC	07/16/2019SE

More from SurGenTec, LLC

510(k)	Device	Decision
K253488	iFuse INTRA Ti Implant SystemOUR · Traditional	02/11/2026SE
K253094	iFuse Bedrock Granite Implant SystemOUR · Special	10/09/2025SE
K251780	iGPS Navigation InstrumentsOLO · Traditional	09/15/2025SE
K241504	iFuse TORQ TNT Implant SystemOUR · Traditional	08/19/2024SE
K241574	iFuse TORQ® Implant SystemOUR · Special	07/02/2024SE
K232800	Navigation Tracking InstrumentsOLO · Traditional	02/23/2024SE
K233508	iFuse Bedrock Granite® Implant SystemOUR · Traditional	01/26/2024SE
K231689	iFuse TORQ® Implant SystemOUR · Special	06/30/2023SE
K222774	iFuse Bedrock Granite® Implant SystemOUR · Traditional	12/22/2022SE
K222605	iFuse TORQ® Implant SystemOUR · Special	09/29/2022SE

Questions and answers

When was Neuromonitoring Kit cleared by the FDA?

Neuromonitoring Kit (K161893) received a 510(k) decision of Substantially Equivalent on October 18, 2016, 99 days after the submission was received.

What is the product code of K161893?

The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.