# K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Dec 26, 2001 after 57 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931154 (1993). 8 ancestors in all.
176 later devices descend from it; 7 cite it directly.
5 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921707: Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2, Pentax Precision Instrument Corp. (1992) Summary page 2.
- K950103: Laparoscope, Hand Instruments, Olympus America, Inc. (1995) Summary page 2.
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment, The Olympus Optical Co. (1998) Summary page 2.

## Most influential descendants
- K021073: Visera Rhinlaryngovideoscope Olympus Enf Type V (2002), 160 descendants of its own
- K052452: Visera Rhino-Laryngovideoscope Olympus Enf Type VT (2005), 159 descendants of its own
- K031648: Visera Rhino-Laryngovideoscope Olympus Enf Type V (2003), 159 descendants of its own
- K061313: Evis Exera 180 System (2006), 158 descendants of its own
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own

## Indications for use
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen. MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP. These instruments have been designed to be used with an Olympus endoscope to collect tissue within the nasal and nasopharyngeal lumen. These instruments has been designed to be used with an Olympus endoscope to retrieve foreign bodies, calculi or resected tissue from the nasal and nasopharyngeal lumen. These instruments has been designed to be used with an Olympus endoscope to collect tissue specimens within the nasal and nasopharyngeal lumen. These instruments has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the nasal and nasopharyngeal lumen. These instruments has been designed to be used with an Olympus endoscope for spraying medications in the nasal and nasopharyngeal lumen.

Source page: https://510kreport.com/device/K013591
Methodology: https://510kreport.com/methodology