510(k) K202027
K202027 is an FDA 510(k) premarket notification submitted by Taeyeon Medical Co., Ltd. for the device "Balex bone Expander System". The FDA issued a decision of Substantially Equivalent on Feb 3, 2021. The device falls under product code HRX (Arthroscope), a Class II device regulated under 21 CFR 888.1100. Taeyeon Medical Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2021
- Date Received
- Jul 22, 2020
- Clearance Type
- Traditional
- 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
- 510(k)
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).