# K972069: Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips, Rechargeable Battery Pack

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jul 29, 1997 after 56 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 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 its predicate without a number.
- (no number) Davol: named in the summary without a submission number
- (no number) Davis+Geck: named in the summary without a submission number

## Most influential descendants
- K991383: Hydrocision Debdridement System (2000), 31 descendants of its own
- K012464: Helix Hydro-Jet (2001), 19 descendants of its own
- K022613: Helix Hydro-Jet (2002), 17 descendants of its own
- K033590: Erbe Helix Hydro-Jet (2004), 16 descendants of its own
- K072404: Erbe Erbejet 2 System (2007), 14 descendants of its own

## Recalls of this device
- Oct 4, 2010 · Not classified · Z-0950-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
- Oct 4, 2010 · Not classified · Z-0947-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
- Oct 4, 2010 · Not classified · Z-0948-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
- Oct 4, 2010 · Not classified · Z-0949-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
- Oct 4, 2010 · Not classified · Z-0953-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
- Oct 4, 2010 · Not classified · Z-0951-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
- Oct 4, 2010 · Not classified · Z-0952-2011: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.

## Indications for use
The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue debridement, and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma.

Source page: https://510kreport.com/device/K972069
Methodology: https://510kreport.com/methodology