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FDA 510(k)

AUSTIN ENDOLYMPH DISPERSMENT SHUNT

K-Number: K834094 · 1984-09-20

ApplicantTreace Medical, Inc.
Decision Date1984-09-20
Product CodeESZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUSTIN ENDOLYMPH DISPERSMENT SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1984-09-20 under 510(k) number K834094. The device is classified under product code ESZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSTIN ENDOLYMPH DISPERSMENT SHUNT?

AUSTIN ENDOLYMPH DISPERSMENT SHUNT is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Treace Medical, Inc.. The 510(k) number is K834094.

When did AUSTIN ENDOLYMPH DISPERSMENT SHUNT receive FDA 510(k) clearance?

AUSTIN ENDOLYMPH DISPERSMENT SHUNT received FDA 510(k) clearance on 1984-09-20, under 510(k) number K834094.

Who is the listed applicant for AUSTIN ENDOLYMPH DISPERSMENT SHUNT?

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

What is the FDA product code for AUSTIN ENDOLYMPH DISPERSMENT SHUNT?

The FDA product code for AUSTIN ENDOLYMPH DISPERSMENT SHUNT is ESZ.

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Other records listing Treace Medical, Inc. 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: ESZ)

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.

K974224ENDOLYMPHATIC SAC TO MASTOID T-SHUNTExmoor Plastics , Ltd.K952227C-FLEX ENDOLYMPHATIC SHUNTTrebay Medical Corp.K897049GIBSON ENDOLYMPHATIC SHUNTHood Laboratories

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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