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FDA 510(k)

REJOYN PENILE SUPPORT SYSTEM

K-Number: K971576 · 1997-10-16

ApplicantAmerican Medtech
Decision Date1997-10-16
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REJOYN PENILE SUPPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Medtech. It received FDA 510(k) clearance on 1997-10-16 under 510(k) number K971576. 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 REJOYN PENILE SUPPORT SYSTEM?

REJOYN PENILE SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is American Medtech. The 510(k) number is K971576.

When did REJOYN PENILE SUPPORT SYSTEM receive FDA 510(k) clearance?

REJOYN PENILE SUPPORT SYSTEM received FDA 510(k) clearance on 1997-10-16, under 510(k) number K971576.

Who is the listed applicant for REJOYN PENILE SUPPORT SYSTEM?

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

What is the FDA product code for REJOYN PENILE SUPPORT SYSTEM?

The FDA product code for REJOYN PENILE SUPPORT SYSTEM 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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