FDA 510(k)

CAP-AID

K-Number: K954959 · 1995-12-06

Decision Date1995-12-06

Product CodeFHA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CAP-AID is the device name listed in this FDA 510(k) record. The listed applicant is Nebl, Inc.. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K954959. 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 CAP-AID?

CAP-AID is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Nebl, Inc.. The 510(k) number is K954959.

When did CAP-AID receive FDA 510(k) clearance?

CAP-AID received FDA 510(k) clearance on 1995-12-06, under 510(k) number K954959.

Who is the listed applicant for CAP-AID?

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

What is the FDA product code for CAP-AID?

The FDA product code for CAP-AID is FHA.

Other records listing Nebl, Inc. 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.

K983164RESTORE (AKA RE/STOR)K971359RESTORE (A.K.A. CAPSURE)

Related Devices (Code: FHA)

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.K952841THE ASSISTANTApple Medical Corp.

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.