# K143705: NeedleCam HD Visualization System

- Pathway: 510(k) (Special)
- Applicant: Biovision Technologies, LLC
- Decided: Feb 20, 2015 after 53 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K833587 (1983). 23 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082293: Surgview Integrated Visualization System, Biovision Technologies, LLC (2008) Summary page 3.

## Most influential descendants
- K252790: Digital ClarusScope System and Digital NeuroPEN System (2026), 0 descendants of its own
- K203526: C Scope Visualization System (2021), 0 descendants of its own

## Indications for use
The NeedleCam HD™ Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

Source page: https://510kreport.com/device/K143705
Methodology: https://510kreport.com/methodology