510(k) K253222
K253222 is an FDA 510(k) premarket notification submitted by Zhejiang Gongdong Medical Technology Co., Ltd. for the device "Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Zhejiang Gongdong Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2025
- Date Received
- September 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type