# K970916: H.V. Pulse Lavage (L31 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Global Medical Products, Inc.
- Decided: Jun 20, 1997 after 100 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- 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) MicroAire® Hi Speed Pulse Lavage 4740: named in the summary without a submission number

## Indications for use
Tava Surgical Instruments’ L31 Series H.V. Pulse Lavage is intended to be utilized in the debridement of the surgical site during trauma cases, hip and knee arthroplasty cases and soft tissue surgery.

Source page: https://510kreport.com/device/K970916
Methodology: https://510kreport.com/methodology