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FDA 510(k)

ODONTO-SCOPE

K-Number: K822562 · 1982-10-06

ApplicantTreace Medical, Inc.
Decision Date1982-10-06
Product CodeFSO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ODONTO-SCOPE 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 1982-10-06 under 510(k) number K822562. The device is classified under product code FSO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODONTO-SCOPE?

ODONTO-SCOPE is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822562.

When did ODONTO-SCOPE receive FDA 510(k) clearance?

ODONTO-SCOPE received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822562.

Who is the listed applicant for ODONTO-SCOPE?

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 ODONTO-SCOPE?

The FDA product code for ODONTO-SCOPE is FSO.

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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: FSO)

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.

K942304MICROFLEXMoeller Microsurgical, Inc.K941399OPERATING MICROSCOPE AA OM 10Appasamy Associates (U.S.A.), Inc.K920689DEEMED MSS -- MICROSCOPE SUPPORT SYSTEMDeemed, Inc.K926288SOM 6VI (SURGICAL OPERATING MICROSCOPE)Jedmed Instrument Co.K931303WOODLYN OPERATION MICROSCOPEWoodlyn, Inc.K926513MOLLER-WEDEL OPERATING MICROSCOPEMoeller Microsurgical, Inc.

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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