# K013617: LTF-240 Pleuravideoscope, Its Accessories and Ancillary Equipments

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Jan 30, 2002 after 86 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923982 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955403: Oes Laparo-Thoraco Videoscope Type V, Olympus America, Inc. (1996) Summary page 2.
- K950103: Laparoscope, Hand Instruments, Olympus America, Inc. (1995) Summary page 2.
- K930215: Flexible Trocar Tubes, Olympus Corp. (1993) Summary page 2.
- K915857: Flexible Tip Thoracoscope/Laparoscope, Olympus Corp. (1994) Summary page 2.

## Recalls of this device
- Mar 23, 2020 · Class II · Z-1762-2020: 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: There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

## Indications for use
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.

Source page: https://510kreport.com/device/K013617
Methodology: https://510kreport.com/methodology
