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FDA 510(k)

UNIVERSAL SPECULUM HOLDER

K-Number: K822370 · 1982-09-09

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

Device Summary

UNIVERSAL SPECULUM HOLDER 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 1982-09-09 under 510(k) number K822370. The device is classified under product code EPY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL SPECULUM HOLDER?

UNIVERSAL SPECULUM HOLDER is a medical device that received FDA 510(k) clearance on 1982-09-09. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822370.

When did UNIVERSAL SPECULUM HOLDER receive FDA 510(k) clearance?

UNIVERSAL SPECULUM HOLDER received FDA 510(k) clearance on 1982-09-09, under 510(k) number K822370.

Who is the listed applicant for UNIVERSAL SPECULUM HOLDER?

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 UNIVERSAL SPECULUM HOLDER?

The FDA product code for UNIVERSAL SPECULUM HOLDER is EPY.

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: EPY)

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.

K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.K925754ECONOMRudolf Riester GmbH & Co. KGK853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.K822373EAR SURGERY SPECULUMTreace Medical, Inc.K822164EAR SPECULIKelleher Corp.

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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