# K961713: Instrument Set for Arthroscopic Percutaneous Discectomy

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: May 31, 1996 after 29 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
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 KSEA instrument set for arthroscopic percutaneous discectomy is designed to be used to visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control.

Source page: https://510kreport.com/device/K961713
Methodology: https://510kreport.com/methodology