# K973068: Ksea Instrument Set for Saphenous Vein Harvesting

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoskop GmbH
- Decided: Nov 7, 1997 after 81 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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
These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.

Source page: https://510kreport.com/device/K973068
Methodology: https://510kreport.com/methodology