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FDA 510(k)

GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS

K-Number: K111458 · 2011-12-01

ApplicantGri Medical & Electronic Technology Co., Ltd.
Decision Date2011-12-01
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K111458. 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 GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS?

GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Gri Medical & Electronic Technology Co., Ltd.. The 510(k) number is K111458.

When did GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS receive FDA 510(k) clearance?

GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS received FDA 510(k) clearance on 2011-12-01, under 510(k) number K111458.

Who is the listed applicant for GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS?

The FDA 510(k) record lists Gri Medical & Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS?

The FDA product code for GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS 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 Gri Medical & Electronic Technology Co., Ltd. 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.

K172835GRI-Alleset Veress NeedleK172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerK102652NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS

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

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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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