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510(k) K212556

mi-eye 3 needlescope with cannula, mi-tablet 3 by Trice Medical, Inc. — Product Code HRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2021
Date Received
August 13, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arthroscope
Device Class
Class II
Regulation Number
888.1100
Review Panel
OR
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Trice Medical, Inc.

  • K241700 — Tenex 2nd Generation System (November 18, 2024)
  • K162475 — mi-eye 2, mi-eye 2 monitor (September 16, 2016)
  • K141119 — CAMERA ENABLED PROBE (July 29, 2014)

Other clearances for product code HRX

  • K252546 — VantageTM Lumbar Decompression Kit (March 12, 2026)
  • K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet ( (December 23, 2025)
  • K250795 — PUREVUE™ FMS (December 5, 2025)
  • K252666 — Articulator Arthroscopic Bur (November 21, 2025)
  • K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
  • K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
  • K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
  • K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
  • K241990 — SpineSite Endoscope System (July 30, 2025)
  • K243602 — Arthrex Spine Endoscope (May 16, 2025)