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FDA 510(k)

ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS

K-Number: K993343 · 2000-03-20

ApplicantErecxel Enterprises
Decision Date2000-03-20
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS is the device name listed in this FDA 510(k) record. The listed applicant is Erecxel Enterprises. It received FDA 510(k) clearance on 2000-03-20 under 510(k) number K993343. 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 ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS?

ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS is a medical device that received FDA 510(k) clearance on 2000-03-20. The listed applicant is Erecxel Enterprises. The 510(k) number is K993343.

When did ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS receive FDA 510(k) clearance?

ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS received FDA 510(k) clearance on 2000-03-20, under 510(k) number K993343.

Who is the listed applicant for ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS?

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

What is the FDA product code for ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS?

The FDA product code for ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS 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.

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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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