# K171402: KARL STORZ Slim Nasopharyngolaryngoscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Feb 2, 2018 after 266 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945381 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981458: Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and Broncho-Fiberscope,11001RK, 11002BC & 110, Karl Storz Endoscopy (1998) Summary page 4.
- K030857: Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic Accessories, Mahe Intl., Inc. (2003) Summary page 4.

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1054-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
The KARL STORZ Slim Nasopharyngolaryngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.

Source page: https://510kreport.com/device/K171402
Methodology: https://510kreport.com/methodology