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FDA 510(k)

SILICONE SOFT-PAK EPISTAXIS CATHETER

K-Number: K832476 · 1983-11-03

ApplicantAxiom Medical, Inc.
Decision Date1983-11-03
Product CodeENW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILICONE SOFT-PAK EPISTAXIS CATHETER 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 1983-11-03 under 510(k) number K832476. The device is classified under product code ENW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE SOFT-PAK EPISTAXIS CATHETER?

SILICONE SOFT-PAK EPISTAXIS CATHETER is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K832476.

When did SILICONE SOFT-PAK EPISTAXIS CATHETER receive FDA 510(k) clearance?

SILICONE SOFT-PAK EPISTAXIS CATHETER received FDA 510(k) clearance on 1983-11-03, under 510(k) number K832476.

Who is the listed applicant for SILICONE SOFT-PAK EPISTAXIS CATHETER?

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 SILICONE SOFT-PAK EPISTAXIS CATHETER?

The FDA product code for SILICONE SOFT-PAK EPISTAXIS CATHETER is ENW.

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Other records listing Axiom Medical, Inc. as applicant

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Related Devices (Code: ENW)

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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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