510(k) K192637
K192637 is an FDA 510(k) premarket notification submitted by Yunyi (Beijing) Medical Device Co., Ltd. for the device "High Strength Suture". The FDA issued a decision of Substantially Equivalent on Mar 2, 2020. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Yunyi (Beijing) Medical Device Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 2020
- Date Received
- Sep 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type
- 510(k)