GF-UE160-AL5 ULTRASOUND ENDOSCOPE
FDA 510(k) clearance K051541 · decided 2005-07-01
Clearance details
- K-number
- K051541
- Device name
- GF-UE160-AL5 ULTRASOUND ENDOSCOPE
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-10
- Decision date
- 2005-07-01
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FDF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endosc recall (Z-0333-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |