STRYKER T4 HYTREL TOGA— 510(k) K070078

Clearance details

Applicant

Stryker Instruments, Instruments Div.

Product code

Code FYA

Device class

Class 2

Regulation

21 CFR 878.4040

Advisory panel

General, Plastic Surgery

Date received

2007-01-09

Decision date

2007-02-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Kalamazoo, MI, US

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• Z-1500-2018 — T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1501-2018 — T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1502-2018 — T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1503-2018 — T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1504-2018 — T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1505-2018 — T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1506-2018 — T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1507-2018 — T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1508-2018 — T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1509-2018 — T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1510-2018 — T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garmentClass II·Terminated·Stryker Instruments Div. of Stryker Corporation·20180223
• Z-1489-2013 — Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1490-2013 — Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1491-2013 — Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1492-2013 — Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1493-2013 — Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1494-2013 — Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1495-2013 — Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1496-2013 — Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523
• Z-1497-2013 — Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20130523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070078.