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FDA 510(k)

HANDLER CATHETER

K-Number: K770562 · 1977-03-24

ApplicantJanet Beach, Ltd.
Decision Date1977-03-24
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HANDLER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Janet Beach, Ltd.. It received FDA 510(k) clearance on 1977-03-24 under 510(k) number K770562. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDLER CATHETER?

HANDLER CATHETER is a medical device that received FDA 510(k) clearance on 1977-03-24. The listed applicant is Janet Beach, Ltd.. The 510(k) number is K770562.

When did HANDLER CATHETER receive FDA 510(k) clearance?

HANDLER CATHETER received FDA 510(k) clearance on 1977-03-24, under 510(k) number K770562.

Who is the listed applicant for HANDLER CATHETER?

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

What is the FDA product code for HANDLER CATHETER?

The FDA product code for HANDLER CATHETER is KOD.

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Related Devices (Code: KOD)

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

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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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