Tricera Arthroscopic System +10 more— 510(k) K233493

Name: FDA 510(k) clearance K233493
Creator: U.S. Food and Drug Administration
Published: 2023-11-28

Substantially Equivalent

Relign Corporation

FDA 510(k) clearance K233493 for Tricera Arthroscopic System +10 more, Substantially Equivalent on 2023-11-28. Applicant: Relign Corporation. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Relign Corporation
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2023-10-30
Decision date: 2023-11-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Campbell, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.