# K981286: Superflow Irrigation and Aspiration Tubing Sets

- Pathway: 510(k) (Traditional)
- Applicant: Armm, Inc.
- Decided: Jun 19, 1998 after 72 days
- Product code: KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K923201 (1993). 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)
- K923201: Endosi Suction Irrigator, Armm, Inc. (1993) Summary page 1.

## Indications for use
T'he irrigation tubing scts will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The scts will be attached to standard irrigation systems such as either gravity bag systems attached to [.V. poles or to standard pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irngant. The handle or accessory for irrigation would be attached to the end opposite the irrigant source. The aspiration tubing sets will be used for the removal of fluids, air or debris lefl after or during the surgery. These sets could be used just to remove the flushing irrigant that is used to keep the surgical arena visible. One end would be attached to the suction source and the other end would be attached to the suction tip handle.

Source page: https://510kreport.com/device/K981286
Methodology: https://510kreport.com/methodology