# K060243: Olympus Guide Sheath, Model XBO1-836-13

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jun 23, 2006 after 143 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931154 (1993). 1 ancestor in all.
11 later devices descend from it; 4 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 1.

## Most influential descendants
- K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) (2013), 5 descendants of its own
- K142934: CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (2015), 2 descendants of its own
- K192164: Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR (2020), 1 descendant of its own
- K172955: LungVision Tool (2018), 1 descendant of its own
- K254037: LungFlow Airway Catheter (2026), 0 descendants of its own

## Recalls of this device
- Jan 15, 2025 · Class I · Z-1071-2025: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
- Jan 4, 2021 · Class II · Z-0973-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0970-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0971-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0972-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1050-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1052-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1051-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-1053-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

## Indications for use
This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.

Source page: https://510kreport.com/device/K060243
Methodology: https://510kreport.com/methodology