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FDA 510(k)

ViVi® Toga Premium

K-Number: K243522 · 2025-05-30

ApplicantThi Total Healthcare Innovation GmbH
Decision Date2025-05-30
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ViVi® Toga Premium is the device name listed in this FDA 510(k) record. The listed applicant is Thi Total Healthcare Innovation GmbH. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243522. 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 ViVi® Toga Premium?

ViVi® Toga Premium is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Thi Total Healthcare Innovation GmbH. The 510(k) number is K243522.

When did ViVi® Toga Premium receive FDA 510(k) clearance?

ViVi® Toga Premium received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243522.

Who is the listed applicant for ViVi® Toga Premium?

The FDA 510(k) record lists Thi Total Healthcare Innovation GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViVi® Toga Premium?

The FDA product code for ViVi® Toga Premium is FYA.

Other records listing Thi Total Healthcare Innovation GmbH as applicant

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.

K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

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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