Synergetics PHOTON EX
FDA 510(k) clearance K143123 · decided 2015-02-24
Clearance details
- K-number
- K143123
- Device name
- Synergetics PHOTON EX
- Applicant
- Synergetics
- Decision
- Substantially Equivalent
- Date received
- 2014-10-31
- Decision date
- 2015-02-24
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- MPA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- O' Fallon, MO, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.