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FDA 510(k)

MSI SURGICAL DRAPES

K-Number: K974672 · 1998-03-13

ApplicantMedical Specialty Innovations, Inc. (Msi)
Decision Date1998-03-13
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MSI SURGICAL DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialty Innovations, Inc. (Msi). It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K974672. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSI SURGICAL DRAPES?

MSI SURGICAL DRAPES is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Medical Specialty Innovations, Inc. (Msi). The 510(k) number is K974672.

When did MSI SURGICAL DRAPES receive FDA 510(k) clearance?

MSI SURGICAL DRAPES received FDA 510(k) clearance on 1998-03-13, under 510(k) number K974672.

Who is the listed applicant for MSI SURGICAL DRAPES?

The FDA 510(k) record lists Medical Specialty Innovations, Inc. (Msi) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MSI SURGICAL DRAPES?

The FDA product code for MSI SURGICAL DRAPES is KKX.

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.

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Other records listing Medical Specialty Innovations, Inc. (Msi) 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.

K972117MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, 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.

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