510(k) K241008
K241008 is an FDA 510(k) premarket notification submitted by Relign Corporation, Subsidiary of Zimmer Biomet for the device "Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (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 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)". The FDA issued a decision of Substantially Equivalent on May 8, 2024. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2024
- Date Received
- April 12, 2024
- 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).