Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Stryker Steri-Shield 8 Surgical Hoods and Togas

K-Number: K241272 · 2024-10-16

ApplicantStryker Instruments
Decision Date2024-10-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2024-10-16 under approval 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. It is manufactured by Stryker Instruments. The 510(k) number is K241272.

When was Stryker Steri-Shield 8 Surgical Hoods and Togas approved by the FDA?

Stryker Steri-Shield 8 Surgical Hoods and Togas received FDA 510(k) clearance on 2024-10-16, under approval number K241272.

What company makes Stryker Steri-Shield 8 Surgical Hoods and Togas?

Stryker Steri-Shield 8 Surgical Hoods and Togas is manufactured by Stryker Instruments.

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.

Related Clinical Trials

NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Other Devices by Stryker Instruments

K172367Stryker Integrated Bipolar Cord and Tubing Sets K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement K223294SpineJack® Expansion Kit K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) K233300POWEReam 1/4 Drive K242266PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

View all 19 devices →

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

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.

↑