Pentaflush
FDA 510(k) clearance K214080 · decided 2022-07-20
Clearance details
- K-number
- K214080
- Device name
- Pentaflush
- Applicant
- Pentaferte Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-27
- Decision date
- 2022-07-20
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Campli Teramo, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.