# K212667: Single Use Guide Sheath Kit-401, K-402

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 22, 2021 after 30 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: 11 generations back to K931154 (1993). 35 ancestors in all.
No later device cites it as a predicate yet.
5 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192164: Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR, Olympus Medical Systems Corp. (2020) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K212667
Methodology: https://510kreport.com/methodology