Decision Date2024-10-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Stryker Steri-Shield 8 Surgical Hoods and Togas is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K241272. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stryker Steri-Shield 8 Surgical Hoods and Togas?
Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Stryker Instruments. The 510(k) number is K241272.
When did Stryker Steri-Shield 8 Surgical Hoods and Togas receive FDA 510(k) clearance?
Stryker Steri-Shield 8 Surgical Hoods and Togas received FDA 510(k) clearance on 2024-10-16, under 510(k) number K241272.
Who is the listed applicant for Stryker Steri-Shield 8 Surgical Hoods and Togas?
The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stryker Steri-Shield 8 Surgical Hoods and Togas?
The FDA product code for Stryker Steri-Shield 8 Surgical Hoods and Togas is FYA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.