# K971649: Ksea Arthropump Plus

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Oct 29, 1997 after 176 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K093471: Karl Storz Arthropump Power Irrigation/Suction Pump (2010), 0 descendants of its own

## Indications for use
These instruments are intended for use by qualified surgeons and provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures.

Source page: https://510kreport.com/device/K971649
Methodology: https://510kreport.com/methodology