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

FDA 510(k)

MED-GUARD SURGEON'S GOWN

K-Number: K992445 · 2000-02-18

ApplicantKappler USA
Decision Date2000-02-18
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MED-GUARD SURGEON'S GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Kappler USA. It received FDA 510(k) clearance on 2000-02-18 under 510(k) number K992445. 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 MED-GUARD SURGEON'S GOWN?

MED-GUARD SURGEON'S GOWN is a medical device that received FDA 510(k) clearance on 2000-02-18. The listed applicant is Kappler USA. The 510(k) number is K992445.

When did MED-GUARD SURGEON'S GOWN receive FDA 510(k) clearance?

MED-GUARD SURGEON'S GOWN received FDA 510(k) clearance on 2000-02-18, under 510(k) number K992445.

Who is the listed applicant for MED-GUARD SURGEON'S GOWN?

The FDA 510(k) record lists Kappler USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED-GUARD SURGEON'S GOWN?

The FDA product code for MED-GUARD SURGEON'S GOWN is FYA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kappler USA 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.

K963809COOL-ZONE

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.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, LLC

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.

↑