510(k) K202291
K202291 is an FDA 510(k) premarket notification submitted by Yunyi (Beijing) Medical Device Co., Ltd. for the device "Button Loop". The FDA issued a decision of Substantially Equivalent on Jan 8, 2021. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Yunyi (Beijing) Medical Device Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 2021
- Date Received
- Aug 12, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)