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FDA 510(k)

MICROSCOPE

K-Number: K822561 · 1982-09-14

ApplicantTreace Medical, Inc.
Decision Date1982-09-14
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROSCOPE 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 1982-09-14 under 510(k) number K822561. The device is classified under product code EPT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCOPE?

MICROSCOPE is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822561.

When did MICROSCOPE receive FDA 510(k) clearance?

MICROSCOPE received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822561.

Who is the listed applicant for MICROSCOPE?

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 MICROSCOPE?

The FDA product code for MICROSCOPE is EPT.

Related Clinical Trials

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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: EPT)

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.

K942233MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEMCarl Zeiss, Inc.K931284MICRODYNE OFFICE SURGICAL MICROSCOPEMicrodyne, Inc.K933310MICRINS CONTRAST BACKGROUND MATERIALMicrins Surgical, Inc.K903412STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.Storz Instrument Co.K883581OPMI CSCarl Zeiss, Inc.K882269STORZ DIAGNOSTIC MICROSCOPE SYSTEMStorz Instrument Co.

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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