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FDA 510(k)

CATHETERS, DRAINAGE

K-Number: K771048 · 1977-07-19

ApplicantAxiom Medical, Inc.
Decision Date1977-07-19
Product CodeFEG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETERS, DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1977-07-19 under 510(k) number K771048. The device is classified under product code FEG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETERS, DRAINAGE?

CATHETERS, DRAINAGE is a medical device that received FDA 510(k) clearance on 1977-07-19. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K771048.

When did CATHETERS, DRAINAGE receive FDA 510(k) clearance?

CATHETERS, DRAINAGE received FDA 510(k) clearance on 1977-07-19, under 510(k) number K771048.

Who is the listed applicant for CATHETERS, DRAINAGE?

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

What is the FDA product code for CATHETERS, DRAINAGE?

The FDA product code for CATHETERS, DRAINAGE is FEG.

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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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