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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) 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. The listed applicant is Zimmer Surgical, Inc.. The 510(k) number is K192194.

When did TotalShield II Surgical Helmet System receive FDA 510(k) clearance?

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

Who is the listed applicant for TotalShield II Surgical Helmet System?

The FDA 510(k) record lists Zimmer Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLCK253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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