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FDA 510(k)

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE

K-Number: K905015 · 1990-12-28

ApplicantSurgitek
Decision Date1990-12-28
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1990-12-28 under 510(k) number K905015. 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 SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE?

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE is a medical device that received FDA 510(k) clearance on 1990-12-28. The listed applicant is Surgitek. The 510(k) number is K905015.

When did SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE receive FDA 510(k) clearance?

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE received FDA 510(k) clearance on 1990-12-28, under 510(k) number K905015.

Who is the listed applicant for SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE?

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

What is the FDA product code for SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE?

The FDA product code for SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE is LKY.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPS

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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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