SITZMARKS
FDA 510(k) clearance K181750 · decided 2018-11-15
Clearance details
- K-number
- K181750
- Device name
- SITZMARKS
- Applicant
- Konsyl Pharmaceuticals
- Decision
- Substantially Equivalent
- Date received
- 2018-07-02
- Decision date
- 2018-11-15
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Easton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.