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FDA 510(k)

TotalShield II Surgical Helmet System

K-Number: K192194 · 2019-10-15

ApplicantZimmer Surgical, Inc.
Decision Date2019-10-15
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TotalShield II Surgical Helmet System is a medical device manufactured by Zimmer Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-15 under approval number K192194. 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 TotalShield II Surgical Helmet System?

TotalShield II Surgical Helmet System is a medical device that received FDA 510(k) clearance on 2019-10-15. It is manufactured by Zimmer Surgical, Inc.. The 510(k) number is K192194.

When was TotalShield II Surgical Helmet System approved by the FDA?

TotalShield II Surgical Helmet System received FDA 510(k) clearance on 2019-10-15, under approval number K192194.

What company makes TotalShield II Surgical Helmet System?

TotalShield II Surgical Helmet System is manufactured by Zimmer Surgical, Inc..

What is the FDA product code for TotalShield II Surgical Helmet System?

The FDA product code for TotalShield II Surgical Helmet System is FYA.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: 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.

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