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FDA 510(k)

Titan Manufacturing Bipolar Forceps

K-Number: K213386 · 2021-10-25

ApplicantTitan Manufacturing, Inc.
Decision Date2021-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Titan Manufacturing Bipolar Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Titan Manufacturing, Inc.. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K213386. 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 Titan Manufacturing Bipolar Forceps?

Titan Manufacturing Bipolar Forceps is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Titan Manufacturing, Inc.. The 510(k) number is K213386.

When did Titan Manufacturing Bipolar Forceps receive FDA 510(k) clearance?

Titan Manufacturing Bipolar Forceps received FDA 510(k) clearance on 2021-10-25, under 510(k) number K213386.

Who is the listed applicant for Titan Manufacturing Bipolar Forceps?

The FDA 510(k) record lists Titan Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Titan Manufacturing Bipolar Forceps?

The FDA product code for Titan Manufacturing Bipolar Forceps is GEI.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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