# K961791: Depuy Disposable Filter/Hood

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Aug 9, 1996 after 92 days
- Product code: LYU (Accessory, Surgical Apparel)
- Device class: 1
- Regulation: 21 CFR 878.4040
- 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) Stryker Steri-Shield Personal Protection System: named in the summary without a submission number
- (no number) DePuy Sterile View Disposable Hood/Gown: named in the summary without a submission number

## Indications for use
The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K961791
Methodology: https://510kreport.com/methodology