Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
FDA 510(k) clearance K231666 · decided 2023-12-13
Clearance details
- K-number
- K231666
- Device name
- Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-06-07
- Decision date
- 2023-12-13
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.