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FDA 510(k)

ERECTION DEVICE

K-Number: K896061 · 1990-03-07

ApplicantClyde Engineering Service
Decision Date1990-03-07
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Clyde Engineering Service. It received FDA 510(k) clearance on 1990-03-07 under 510(k) number K896061. 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 ERECTION DEVICE?

ERECTION DEVICE is a medical device that received FDA 510(k) clearance on 1990-03-07. The listed applicant is Clyde Engineering Service. The 510(k) number is K896061.

When did ERECTION DEVICE receive FDA 510(k) clearance?

ERECTION DEVICE received FDA 510(k) clearance on 1990-03-07, under 510(k) number K896061.

Who is the listed applicant for ERECTION DEVICE?

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

What is the FDA product code for ERECTION DEVICE?

The FDA product code for ERECTION DEVICE is LKY.

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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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