# K960046: Surgical Dynamics 30K Working Channel Scope

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Dynamics, Inc.
- Decided: Apr 2, 1996 after 91 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 its predicate without a number.
- (no number) Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy: named in the summary without a submission number
- (no number) Argus Medical Company Laparoscopic Discectomy Instrument System: named in the summary without a submission number
- (no number) Nucleotome System and Probe Kits: named in the summary without a submission number

## Indications for use
The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct visualization during a laparoscopic procedure.

Source page: https://510kreport.com/device/K960046
Methodology: https://510kreport.com/methodology