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FDA 510(k)

O'NEIL URINARY CATHETER INTRODUCER

K-Number: K884819 · 1989-02-17

ApplicantMedical Marketing Group
Decision Date1989-02-17
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

O'NEIL URINARY CATHETER INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Marketing Group. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K884819. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O'NEIL URINARY CATHETER INTRODUCER?

O'NEIL URINARY CATHETER INTRODUCER is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Medical Marketing Group. The 510(k) number is K884819.

When did O'NEIL URINARY CATHETER INTRODUCER receive FDA 510(k) clearance?

O'NEIL URINARY CATHETER INTRODUCER received FDA 510(k) clearance on 1989-02-17, under 510(k) number K884819.

Who is the listed applicant for O'NEIL URINARY CATHETER INTRODUCER?

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

What is the FDA product code for O'NEIL URINARY CATHETER INTRODUCER?

The FDA product code for O'NEIL URINARY CATHETER INTRODUCER is KNY.

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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 Marketing Group 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.

K910022MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KITK874682MMG CATHETER PLUG W/DRAINAGE TUBE COVERK871999MMG URO-SELF CATHETERK863912THE MMG 5 IN 1 CONNECTORK840838MMG CONNECTIVE TUBINGK821168DISPOSABLE URINARY LEGBAG W/STRAP

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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