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FDA 510(k)

COLONRING

K-Number: K093661 · 2011-02-10

ApplicantNiti Surgical Solutions, Ltd.
Decision Date2011-02-10
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COLONRING is the device name listed in this FDA 510(k) record. The listed applicant is Niti Surgical Solutions, Ltd.. It received FDA 510(k) clearance on 2011-02-10 under 510(k) number K093661. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLONRING?

COLONRING is a medical device that received FDA 510(k) clearance on 2011-02-10. The listed applicant is Niti Surgical Solutions, Ltd.. The 510(k) number is K093661.

When did COLONRING receive FDA 510(k) clearance?

COLONRING received FDA 510(k) clearance on 2011-02-10, under 510(k) number K093661.

Who is the listed applicant for COLONRING?

The FDA 510(k) record lists Niti Surgical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONRING?

The FDA product code for COLONRING is FZP.

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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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