# K982428: Christoudias Gauze Dissector (Laparoscopic Hand Instrument)

- Pathway: 510(k) (Traditional)
- Applicant: Innervision, Inc.
- Decided: Oct 9, 1998 after 88 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Christoudias Gauze Dissector is indicated for laparoscopic general surgical procedures where blotting small bleeders and/or sponging tissue in a viable atraumatic way would be advantageous.

Source page: https://510kreport.com/device/K982428
Methodology: https://510kreport.com/methodology