SimplCath
FDA 510(k) clearance K182511 · decided 2019-03-20
Clearance details
- K-number
- K182511
- Device name
- SimplCath
- Applicant
- F&S Medical Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-09-12
- Decision date
- 2019-03-20
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- GBM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Omaha, NE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.