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FDA 510(k)

T-TUBE INSERTER

K-Number: K831590 · 1983-06-15

ApplicantTreace Medical, Inc.
Decision Date1983-06-15
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

T-TUBE INSERTER 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 1983-06-15 under 510(k) number K831590. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-TUBE INSERTER?

T-TUBE INSERTER is a medical device that received FDA 510(k) clearance on 1983-06-15. The listed applicant is Treace Medical, Inc.. The 510(k) number is K831590.

When did T-TUBE INSERTER receive FDA 510(k) clearance?

T-TUBE INSERTER received FDA 510(k) clearance on 1983-06-15, under 510(k) number K831590.

Who is the listed applicant for T-TUBE INSERTER?

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 T-TUBE INSERTER?

The FDA product code for T-TUBE INSERTER is EQH.

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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: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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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