OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
FDA 510(k) clearance K011314 · decided 2001-05-15
Clearance details
- K-number
- K011314
- Device name
- OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
- Applicant
- Aloka Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-30
- Decision date
- 2001-05-15
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wallingford, CT, 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 |
| Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound i recall (Z-1034-2022) | Olympus Corporation of the Americas | 2022-05-05 |