OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM— 510(k) K011314

Clearance details

Applicant

Aloka Co., Ltd.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2001-04-30

Decision date

2001-05-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wallingford, CT, US

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• K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM2011-05-13
• K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM2011-02-17
• K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM2009-11-20
• K083254 — ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM2008-12-19
• K081843 — ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS12008-07-15

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0333-2024 — Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.Class II·Ongoing·Aizu Olympus Co., Ltd.·20230925
• Z-1034-2022 — Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.Class II·Ongoing·Olympus Corporation of the Americas·20220318
• Z-0498-2021 — Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.Class II·Terminated·Olympus Corporation of the Americas·20201016
• Z-0499-2021 — Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.Class II·Terminated·Olympus Corporation of the Americas·20201016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011314.