# K070360: Kirwan Disposable 23KHZ Manifold Tubing, 40-3600, & 36KHZ Manifold Tubing, 40-3601

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Aug 7, 2007 after 181 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- 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) C3600, 23 kHz Manifold Tubing (Integra LifeSciences): named in the summary without a submission number
- (no number) C3601, 36 kHz Manifold Tubing (Integra LifeSciences): named in the summary without a submission number

## Indications for use
These tubing sets are designed to function as Manifold Tubing for the CUSA EXceITM Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate hand-piece, providing for both irrigation and aspiration of the surgical site.

Source page: https://510kreport.com/device/K070360
Methodology: https://510kreport.com/methodology