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FDA 510(k)

MRI NEURO DRAPE

K-Number: K091343 · 2009-09-22

ApplicantSurgivision, Inc.
Decision Date2009-09-22
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MRI NEURO DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgivision, Inc.. It received FDA 510(k) clearance on 2009-09-22 under 510(k) number K091343. 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 MRI NEURO DRAPE?

MRI NEURO DRAPE is a medical device that received FDA 510(k) clearance on 2009-09-22. The listed applicant is Surgivision, Inc.. The 510(k) number is K091343.

When did MRI NEURO DRAPE receive FDA 510(k) clearance?

MRI NEURO DRAPE received FDA 510(k) clearance on 2009-09-22, under 510(k) number K091343.

Who is the listed applicant for MRI NEURO DRAPE?

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

What is the FDA product code for MRI NEURO DRAPE?

The FDA product code for MRI NEURO DRAPE is KKX.

Related Clinical Trials

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Other records listing Surgivision, Inc. 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.

K102101SURGIVISION MR COMPATIBLE VENTRICULAR CANNULAK100836CLEARPOINT SYSTEMK091439HEAD FIXATION ARC AND TABLE BASE

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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