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510(k) K251653

SPRY TMS Therapy System (0550) by Soterix Medical, Inc. — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
May 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator
Device Class
Class II
Regulation Number
882.5805
Review Panel
NE
Submission Type

A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.

Other clearances by Soterix Medical, Inc.

  • K233751 — Milieve (YPS-301BD) (June 3, 2024)
  • K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
  • K192823 — MEGA-TMS (August 13, 2021)
  • K191422 — Neural Navigator (April 6, 2020)
  • K170291 — IontoDC (May 1, 2017)

Other clearances for product code OBP

  • K251391 — BrainsWay Deep TMS System (November 7, 2025)
  • K250689 — CloudTMS Edge (September 14, 2025)
  • K251449 — BrainsWay Deep TMS System (September 13, 2025)
  • K243700 — Apollo TMS Therapy System (September 4, 2025)
  • K243539 — Apollo TMS Therapy System (August 18, 2025)
  • K251125 — MagVenture TMS Therapy System (August 11, 2025)
  • K251119 — MagVenture TMS Therapy System (August 8, 2025)
  • K252032 — T65 (9016E061-) (July 30, 2025)
  • K251210 — Ampa One System (AMPA-001) (June 27, 2025)
  • K243460 — Ultimate rTMS (April 17, 2025)