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FDA 510(k)

CAP-AID (IMPROVED)

K-Number: K964580 · 1997-01-10

ApplicantNebel, Inc.
Decision Date1997-01-10
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAP-AID (IMPROVED) is the device name listed in this FDA 510(k) record. The listed applicant is Nebel, Inc.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K964580. 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 (IMPROVED)?

CAP-AID (IMPROVED) is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Nebel, Inc.. The 510(k) number is K964580.

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

CAP-AID (IMPROVED) received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964580.

Who is the listed applicant for CAP-AID (IMPROVED)?

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

What is the FDA product code for CAP-AID (IMPROVED)?

The FDA product code for CAP-AID (IMPROVED) is FHA.

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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.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, Inc.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.

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