510(k) K213223
K213223 is an FDA 510(k) premarket notification submitted by Beijing Zksk Technology Co., Ltd. for the device "Multi-Band Ligator". The FDA issued a decision of Substantially Equivalent on June 6, 2022. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Beijing Zksk Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2022
- Date Received
- September 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type