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FDA 510(k)

VTU-1 VACUUM ERECTION SYSTEM

K-Number: K971257 · 1997-10-03

ApplicantMckenna & Cuneo
Decision Date1997-10-03
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VTU-1 VACUUM ERECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mckenna & Cuneo. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K971257. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VTU-1 VACUUM ERECTION SYSTEM?

VTU-1 VACUUM ERECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Mckenna & Cuneo. The 510(k) number is K971257.

When did VTU-1 VACUUM ERECTION SYSTEM receive FDA 510(k) clearance?

VTU-1 VACUUM ERECTION SYSTEM received FDA 510(k) clearance on 1997-10-03, under 510(k) number K971257.

Who is the listed applicant for VTU-1 VACUUM ERECTION SYSTEM?

The FDA 510(k) record lists Mckenna & Cuneo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VTU-1 VACUUM ERECTION SYSTEM?

The FDA product code for VTU-1 VACUUM ERECTION SYSTEM is LKY.

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 Mckenna & Cuneo 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.

K936312MANUAL MASSAGE ROLLERK944547DANTEC KEYPOINT

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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