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FDA 510(k)

INSTRUMENT GUARD CAPSULE

K-Number: K831588 · 1983-06-15

ApplicantTreace Medical, Inc.
Decision Date1983-06-15
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT GUARD CAPSULE 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 K831588. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT GUARD CAPSULE?

INSTRUMENT GUARD CAPSULE 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 K831588.

When did INSTRUMENT GUARD CAPSULE receive FDA 510(k) clearance?

INSTRUMENT GUARD CAPSULE received FDA 510(k) clearance on 1983-06-15, under 510(k) number K831588.

Who is the listed applicant for INSTRUMENT GUARD CAPSULE?

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 INSTRUMENT GUARD CAPSULE?

The FDA product code for INSTRUMENT GUARD CAPSULE is KCT.

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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: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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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