LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS— 510(k) K013617
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K013617 for LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS, Substantially Equivalent on 2002-01-30. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
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More clearances from Olympus Optical Co., Ltd.
view all- K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 →
Recalls naming K013617
K-number listed on FDA's recall record- Z-1762-2020 — Olympus Pleuravideoscope, Model LTF-160
- Z-1763-2020 — Olympus Pleuravideoscope, Model LTF-240
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013617.
Data sourced from openFDA. This site is unofficial and independent of the FDA.