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FDA 510(k)

SPRY TMS Therapy System (0550)

K-Number: K251653 · 2026-02-20

ApplicantSoterix Medical, Inc.
Decision Date2026-02-20
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRY TMS Therapy System (0550) is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K251653. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRY TMS Therapy System (0550)?

SPRY TMS Therapy System (0550) is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K251653.

When did SPRY TMS Therapy System (0550) receive FDA 510(k) clearance?

SPRY TMS Therapy System (0550) received FDA 510(k) clearance on 2026-02-20, under 510(k) number K251653.

Who is the listed applicant for SPRY TMS Therapy System (0550)?

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

What is the FDA product code for SPRY TMS Therapy System (0550)?

The FDA product code for SPRY TMS Therapy System (0550) is OBP.

Other records listing Soterix Medical, 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.

K233751Milieve (YPS-301BD)K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)K192823MEGA-TMSK191422Neural NavigatorK170291IontoDC

Related Devices (Code: OBP)

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.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251391BrainsWay Deep TMS SystemBrainsway , Ltd.

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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