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FDA 510(k)

EAR APPLICATOR, CATALOG NO. 2229

K-Number: K870762 · 1987-03-06

ApplicantTreace Medical, Inc.
Decision Date1987-03-06
Product CodeKXF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EAR APPLICATOR, CATALOG NO. 2229 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 1987-03-06 under 510(k) number K870762. The device is classified under product code KXF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR APPLICATOR, CATALOG NO. 2229?

EAR APPLICATOR, CATALOG NO. 2229 is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Treace Medical, Inc.. The 510(k) number is K870762.

When did EAR APPLICATOR, CATALOG NO. 2229 receive FDA 510(k) clearance?

EAR APPLICATOR, CATALOG NO. 2229 received FDA 510(k) clearance on 1987-03-06, under 510(k) number K870762.

Who is the listed applicant for EAR APPLICATOR, CATALOG NO. 2229?

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 EAR APPLICATOR, CATALOG NO. 2229?

The FDA product code for EAR APPLICATOR, CATALOG NO. 2229 is KXF.

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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: KXF)

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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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