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FDA 510(k)

ADD-A-CATH

K-Number: K884061 · 1988-10-25

ApplicantFemcare , Ltd.
Decision Date1988-10-25
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADD-A-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Femcare , Ltd.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K884061. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADD-A-CATH?

ADD-A-CATH is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Femcare , Ltd.. The 510(k) number is K884061.

When did ADD-A-CATH receive FDA 510(k) clearance?

ADD-A-CATH received FDA 510(k) clearance on 1988-10-25, under 510(k) number K884061.

Who is the listed applicant for ADD-A-CATH?

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

What is the FDA product code for ADD-A-CATH?

The FDA product code for ADD-A-CATH is KOB.

Other records listing Femcare , Ltd. 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.

K932465LI VASECTOMY

Related Devices (Code: KOB)

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

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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