# K152466: Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: May 19, 2016 after 262 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: 8 generations back to K921244 (1992). 24 ancestors in all.
No later device cites it as a predicate yet.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview, Ambu A/S (2013) Summary page 4.

## Indications for use
The Prosurg’s, Neo-BronchoscopeTM -Digital Video Bronchoscopy System –Rigid & Flexible (which includes Digital Video Bronchoscope, Single use Diagnostic / Operating Outer Sheath) is intended for use for endoscopic examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices & accessories. The, Neo- Bronchoscope achieves its purpose by providing the user with a visual confirmation of where the tip of the endoscope is in the human anatomy. The Neoflex- Bronchoscope allows user to guide the Bronchoscope in the desired location with ease and safety.

Source page: https://510kreport.com/device/K152466
Methodology: https://510kreport.com/methodology