# K122134: Flexlite Camera

- Pathway: 510(k) (Traditional)
- Applicant: Spine View, Inc.
- Decided: Dec 27, 2012 after 162 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: 8 generations back to K833587 (1983). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor, Vision-Sciences, Inc. (2011) Summary page 2.
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor, Vision-Sciences, Inc. (2007) Summary page 2.
- K081051: Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope, Spine View, Inc. (2008) Summary page 2.

## Indications for use
The FlexLiteTM Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Source page: https://510kreport.com/device/K122134
Methodology: https://510kreport.com/methodology