# K192164: Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 6, 2020 after 210 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060243: Olympus Guide Sheath, Model XBO1-836-13, Olympus Medical Systems Corporation (2006) Summary page 6.
- K172726: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D, Olympus Medical Systems Corp. (2018) Summary page 7.
- K190293: Single Use Cytology Brush BC-205D, Olympus Medical Systems Corp. (2019) Summary page 7.

## Most influential descendants
- K212667: Single Use Guide Sheath Kit-401, K-402 (2021), 0 descendants of its own

## Indications for use
Single Use Guide Sheath Kit K-401, K-402 These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only. - Indications for use of each component Single Use Guide Sheath SG-400C The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree. Single Use Biopsy Forceps FB-433D The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope within the tracheobronchial tree. Single Use Cytology Brush BC-205D The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree. Single Use Guiding Device CC-220DR This instrument has been designed to be used with an Olympus endoscope and guide sheath to guide the guide sheath to the respiratory organs and to collect specimens within the respiratory organs. This device is intended for adult patients only.

Source page: https://510kreport.com/device/K192164
Methodology: https://510kreport.com/methodology