510(k) K241272

Stryker Steri-Shield 8 Surgical Hoods and Togas by Stryker Instruments — Product Code FYA

K241272 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "Stryker Steri-Shield 8 Surgical Hoods and Togas". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Stryker Instruments has at least 10 other 510(k) clearances on record.