# K073017: Stryker Stri-Shield Flyte Togas

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments, Instruments Div.
- Decided: Nov 30, 2007 after 36 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944393 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063005: Stryker T6 Hoods and Togas, Stryker Instruments (2007). Our reading of the summary gave K003005, FDA’s number for Tissuelink Bipolar Forceps (Tissuelink Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker T6 Hoods and Togas”. Summary page 1.

## Most influential descendants
- K141095: Stryker Steri-Shield Flyte Hybrid Togas (2014), 0 descendants of its own

## Recalls of this device
- Dec 22, 2014 · Class III · Z-1077-2015: A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-

## Indications for use
The Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Source page: https://510kreport.com/device/K073017
Methodology: https://510kreport.com/methodology