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FDA 510(k)

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE

K-Number: K920409 · 1992-05-11

ApplicantDacomed Corp.
Decision Date1992-05-11
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Dacomed Corp.. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K920409. 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 DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE?

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Dacomed Corp.. The 510(k) number is K920409.

When did DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE receive FDA 510(k) clearance?

DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE received FDA 510(k) clearance on 1992-05-11, under 510(k) number K920409.

Who is the listed applicant for DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE?

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

What is the FDA product code for DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE?

The FDA product code for DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE is LKY.

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Other records listing Dacomed Corp. 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.

K953640DUNA II PENILE PROSTHESISK941781RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMK920420DURA II PENILE PROSTHESISK912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISK900774DACOMED NEGATIVE PRESSURE ERECTION DEVICEK885323DACOMED EXTERNAL MALE CONTINENCE DEVICE

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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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