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510(k) K233493

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) by Relign Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2023
Date Received
October 30, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
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 Relign Corporation

  • K162770 — Relign System (January 4, 2017)

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