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FDA 510(k)

BIPOL CABLE

K-Number: K863412 · 1986-10-02

ApplicantTreace Medical, Inc.
Decision Date1986-10-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOL CABLE 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 1986-10-02 under 510(k) number K863412. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPOL CABLE?

BIPOL CABLE is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is Treace Medical, Inc.. The 510(k) number is K863412.

When did BIPOL CABLE receive FDA 510(k) clearance?

BIPOL CABLE received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863412.

Who is the listed applicant for BIPOL CABLE?

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 BIPOL CABLE?

The FDA product code for BIPOL CABLE is GEI.

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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: GEI)

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.

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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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