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FDA 510(k)

DACOMED EXTERNAL MALE CONTINENCE DEVICE

K-Number: K885323 · 1989-02-08

ApplicantDacomed Corp.
Decision Date1989-02-08
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DACOMED EXTERNAL MALE CONTINENCE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Dacomed Corp.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K885323. The device is classified under product code FHA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DACOMED EXTERNAL MALE CONTINENCE DEVICE?

DACOMED EXTERNAL MALE CONTINENCE DEVICE is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Dacomed Corp.. The 510(k) number is K885323.

When did DACOMED EXTERNAL MALE CONTINENCE DEVICE receive FDA 510(k) clearance?

DACOMED EXTERNAL MALE CONTINENCE DEVICE received FDA 510(k) clearance on 1989-02-08, under 510(k) number K885323.

Who is the listed applicant for DACOMED EXTERNAL MALE CONTINENCE DEVICE?

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 DACOMED EXTERNAL MALE CONTINENCE DEVICE?

The FDA product code for DACOMED EXTERNAL MALE CONTINENCE DEVICE is FHA.

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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: FHA)

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.

K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.K964580CAP-AID (IMPROVED)Nebel, Inc.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, 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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