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FDA 510(k)

HANDI-TRAY

K-Number: K823438 · 1983-01-14

ApplicantTreace Medical, Inc.
Decision Date1983-01-14
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANDI-TRAY 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 1983-01-14 under 510(k) number K823438. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDI-TRAY?

HANDI-TRAY is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Treace Medical, Inc.. The 510(k) number is K823438.

When did HANDI-TRAY receive FDA 510(k) clearance?

HANDI-TRAY received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823438.

Who is the listed applicant for HANDI-TRAY?

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 HANDI-TRAY?

The FDA product code for HANDI-TRAY is FSM.

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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: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., 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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