Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)— 510(k) K231666
Substantially EquivalentFUJIFILM Healthcare Americas Corporation
FDA 510(k) clearance K231666 for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L), Substantially Equivalent on 2023-12-13. Applicant: FUJIFILM Healthcare Americas Corporation.
Clearance details
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.