FDA 510(k)

EAR LOOP

K-Number: K870761 · 1987-03-03

Decision Date1987-03-03

Product CodeJYQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

EAR LOOP 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 1987-03-03 under 510(k) number K870761. The device is classified under product code JYQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR LOOP?

EAR LOOP is a medical device that received FDA 510(k) clearance on 1987-03-03. The listed applicant is Treace Medical, Inc.. The 510(k) number is K870761.

When did EAR LOOP receive FDA 510(k) clearance?

EAR LOOP received FDA 510(k) clearance on 1987-03-03, under 510(k) number K870761.

Who is the listed applicant for EAR LOOP?

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 LOOP?

The FDA product code for EAR LOOP is JYQ.

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 PORP K882349MALLET, SURGICAL K874779BIPOLATOR 50 K873154TREACE MAGNUM OTO-TOOL SYSTEM K872000EYE GARD K870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: JYQ)

K890221MICROSURGICAL WIRE LOOPKinetic Medical Products

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.