510(k) K253773
K253773 is an FDA 510(k) premarket notification submitted by Taizhou Huangyan Guanhong Plastic Steel Products Factory for the device "Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- November 26, 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