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FDA 510(k)

SOFT GRIP UNI-HANDLE

K-Number: K823913 · 1983-01-26

ApplicantTreace Medical, Inc.
Decision Date1983-01-26
Product CodeEJB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOFT GRIP UNI-HANDLE 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 1983-01-26 under 510(k) number K823913. The device is classified under product code EJB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT GRIP UNI-HANDLE?

SOFT GRIP UNI-HANDLE is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Treace Medical, Inc.. The 510(k) number is K823913.

When did SOFT GRIP UNI-HANDLE receive FDA 510(k) clearance?

SOFT GRIP UNI-HANDLE received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823913.

Who is the listed applicant for SOFT GRIP UNI-HANDLE?

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 SOFT GRIP UNI-HANDLE?

The FDA product code for SOFT GRIP UNI-HANDLE is EJB.

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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: EJB)

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.

K023367DETECTAR, MODEL N123-MINeks TechnologiesK981234FLARE,FILE, FILLLone Star TechnologiesK930094AUKUSLEEVEAukland Medical Plastics, Inc.K922633CAVI-ZYMEE&D Dental Products, Inc.K871818SPATULA, DENTAL, CEMENTMilitary Engineering, Inc.K833338TOOTH SLOOTHJoel Lander D.D.S.

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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