PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
FDA 510(k) clearance K251874 · decided 2025-10-14
Clearance details
- K-number
- K251874
- Device name
- PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
- Applicant
- Pureway Compliance, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-18
- Decision date
- 2025-10-14
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Katy, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.