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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HRXArthroscope2Product Code
- K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)2Cleared 510(K)
- K250795PUREVUE™ FMS2Cleared 510(K)
- K252666Articulator Arthroscopic Bur2Cleared 510(K)
- K252458Kyphoplasty Balloon Dilatation Catheters2Cleared 510(K)
- K252594UltraGuideCTR® image guided soft tissue release system2Cleared 510(K)
- K243774ELID (Endoscopic Less Invasive Decompression) System2Cleared 510(K)
- K241990SpineSite Endoscope System2Cleared 510(K)
- K243602Arthrex Spine Endoscope2Cleared 510(K)
- K242417VECTR – Video Endoscopic Carpal Tunnel Release System2Cleared 510(K)
- K243020MIDASVu2Cleared 510(K)
Show All 677 Submissions
- LZEIsometer1Product Code
- NBHAccessories, Arthroscopic1Product Code
- NGRTester, Stiffness, Cartilage, Arthroscopic2Product Code
- PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures2Product Code
- QGQBone Indentation Device2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
UltraGuideCTR® image guided soft tissue release system
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K252594
- 510(k) Type
- Traditional
- Applicant
- Sonex Health
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/29/2025
- Days to Decision
- 45 days
- Submission Type
- Summary