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FDA 510(k)

BIPOLATOR 50

K-Number: K874779 · 1988-01-29

ApplicantTreace Medical, Inc.
Decision Date1988-01-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLATOR 50 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 1988-01-29 under 510(k) number K874779. 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 BIPOLATOR 50?

BIPOLATOR 50 is a medical device that received FDA 510(k) clearance on 1988-01-29. The listed applicant is Treace Medical, Inc.. The 510(k) number is K874779.

When did BIPOLATOR 50 receive FDA 510(k) clearance?

BIPOLATOR 50 received FDA 510(k) clearance on 1988-01-29, under 510(k) number K874779.

Who is the listed applicant for BIPOLATOR 50?

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 BIPOLATOR 50?

The FDA product code for BIPOLATOR 50 is GEI.

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Other records listing Treace Medical, Inc. as applicant

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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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