# K964919: Emerald Medical, Inc. Nucleus Pulposis Evacuator System

- Pathway: 510(k) (Traditional)
- Applicant: Emerald Medical, Inc.
- Decided: Jan 28, 1997 after 50 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: 1 generation back to K941709 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941709: Acufex Arthroscopic Discectomy Systems, Acufex Microsurgical, Inc. (1995) Summary page 1.
- (no number) Smith & Nephew Arthroscopic MicroDiscectomy System (AMD): named in the summary without a submission number
- (no number) Instrument introduction system developed by Acufex Microsurgical: named in the summary without a submission number
- (no number) Instrument introduction system developed by Surgical Dynamics: named in the summary without a submission number
- (no number) Instrument introduction system developed by Sofamor Danek: named in the summary without a submission number
- (no number) Instrument introduction system developed by Smith & Nephew Spine: named in the summary without a submission number

Source page: https://510kreport.com/device/K964919
Methodology: https://510kreport.com/methodology