# K970107: Intubation Endoscope and Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Urohealth Systems, Inc.
- Decided: Nov 18, 1997 after 309 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SteBar Instr. Corp. Schroeder Oral/Nasal Stylette™: named in the summary without a submission number
- (no number) Vision-Sciences EndoSheath®: named in the summary without a submission number
- (no number) AMERICAN OPTICAL Flexible Brochoscope FBS-1: named in the summary without a submission number
- (no number) Karl Storz Intubation Fiberscope: named in the summary without a submission number

## Indications for use
The Intubation Endoscope is used for direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.

Source page: https://510kreport.com/device/K970107
Methodology: https://510kreport.com/methodology