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FDA 510(k)

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE

K-Number: K913448 · 1992-02-07

ApplicantGraham Medical Products
Decision Date1992-02-07
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Graham Medical Products. It received FDA 510(k) clearance on 1992-02-07 under 510(k) number K913448. 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 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE?

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE is a medical device that received FDA 510(k) clearance on 1992-02-07. The listed applicant is Graham Medical Products. The 510(k) number is K913448.

When did DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE receive FDA 510(k) clearance?

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE received FDA 510(k) clearance on 1992-02-07, under 510(k) number K913448.

Who is the listed applicant for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE?

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

What is the FDA product code for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE?

The FDA product code for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE is KKX.

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Other records listing Graham Medical Products 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.

K921657VASECTOMY DRAPEK922100DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEK922059DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599K913447DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599K913560STOPCOCKK903726DRAPE, SURGICAL - UTILITY DRAPE - STERILE

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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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