510(k) · Cleared
Recalled · Class II · 2020LTF-240 Pleuravideoscope, Its Accessories and Ancillary Equipments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 30, 2002 as substantially equivalent to K955403 (Olympus America, Inc., 1996) and 3 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1993. It has been recalled 2 times.
- Decided
- Jan 30, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K923982 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 1 generation backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- This deviceK013617 LTF-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsOlympus Optical Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −1 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K013617 | LTF-240 Pleuravideoscope, Its Accessories and Ancillary Equipments | Olympus Optical Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955403 | Oes Laparo-Thoraco Videoscope Type VSummary page 2….1720 21CFR 876.1500 C. Predicate Devices: Kol 3617 2/2 Model Device Description & Manufacturer Class 410(k)#/Date of Cleared OES Laparo-Thoracoscope #K955403 Olympus Optical Co., II LTF-V Laparoscope, #K950103 Olympus America, Inc. | 1I Hand Instruments Flexible Trocar Tubes #K93021… | 1996 |
| * | K950103 | Laparoscope, Hand InstrumentsSummary page 2…ces: Kol 3617 2/2 Model Device Description & Manufacturer Class 410(k)#/Date of Cleared OES Laparo-Thoracoscope #K955403 Olympus Optical Co., II LTF-V Laparoscope, #K950103 Olympus America, Inc. | 1I Hand Instruments Flexible Trocar Tubes #K930215 Olympus Optical Co., II Flexible Tip #K915857 Olymp… | 1995 |
| * | K930215 | Flexible Trocar TubesSummary page 2…e of Cleared OES Laparo-Thoracoscope #K955403 Olympus Optical Co., II LTF-V Laparoscope, #K950103 Olympus America, Inc. | 1I Hand Instruments Flexible Trocar Tubes #K930215 Olympus Optical Co., II Flexible Tip #K915857 Olympus Optical Co., Thoracoscope/Laparoscope D. Summary Description of the Devi… | 1993 |
| * | K915857 | Flexible Tip Thoracoscope/LaparoscopeSummary page 2…Olympus Optical Co., II LTF-V Laparoscope, #K950103 Olympus America, Inc. | 1I Hand Instruments Flexible Trocar Tubes #K930215 Olympus Optical Co., II Flexible Tip #K915857 Olympus Optical Co., Thoracoscope/Laparoscope D. Summary Description of the Device 1. Summary This subject device “XENF-DP Rhi… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2020 | Class II | Z-1762-2020 | Under Investigation by firm | There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided. |
| Mar 23, 2020 | Class II | Z-1763-2020 | Under Investigation by firm | There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K955403.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013617: LTF-240 Pleuravideoscope, Its Accessories and Ancillary Equipments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013617
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026