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FDA 510(k)

SILICONE-SILVER PENILE PROSTHESIS-ESK

K-Number: K830667 · 1983-10-20

ApplicantDacomed Corp.
Decision Date1983-10-20
Product CodeFTQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILICONE-SILVER PENILE PROSTHESIS-ESK is the device name listed in this FDA 510(k) record. The listed applicant is Dacomed Corp.. It received FDA 510(k) clearance on 1983-10-20 under 510(k) number K830667. The device is classified under product code FTQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE-SILVER PENILE PROSTHESIS-ESK?

SILICONE-SILVER PENILE PROSTHESIS-ESK is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is Dacomed Corp.. The 510(k) number is K830667.

When did SILICONE-SILVER PENILE PROSTHESIS-ESK receive FDA 510(k) clearance?

SILICONE-SILVER PENILE PROSTHESIS-ESK received FDA 510(k) clearance on 1983-10-20, under 510(k) number K830667.

Who is the listed applicant for SILICONE-SILVER PENILE PROSTHESIS-ESK?

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 SILICONE-SILVER PENILE PROSTHESIS-ESK?

The FDA product code for SILICONE-SILVER PENILE PROSTHESIS-ESK is FTQ.

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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 SYSTEMK920409DACOMED BATTERY OPERATED VACUUM ERECTION DEVICEK920420DURA II PENILE PROSTHESISK912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISK900774DACOMED NEGATIVE PRESSURE ERECTION DEVICE

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Related Devices (Code: FTQ)

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.

K983015VIRILIS PENILE PROSTHESISSpecialty Surgical Products, Inc.

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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