# K963642: Incl II Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Mar 18, 1998 after 552 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- 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 no predicate by number.

## Indications for use
The INCLUSIVE® Endoscope is indicated for aiding in the search and removal of nucleus material and for viewing herniated disc material in the lumbar spine via a percutaneous surgical approach. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist and the temporomandibular joint (TMJ).

Source page: https://510kreport.com/device/K963642
Methodology: https://510kreport.com/methodology