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FDA 510(k)

CINCHER-2.6 SUTURE ANCHOR MODEL FG-001

K-Number: K122954 · 2012-12-19

ApplicantFoundry Newcoxi, Inc.
Decision Date2012-12-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 is the device name listed in this FDA 510(k) record. The listed applicant is Foundry Newcoxi, Inc.. It received FDA 510(k) clearance on 2012-12-19 under 510(k) number K122954. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CINCHER-2.6 SUTURE ANCHOR MODEL FG-001?

CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 is a medical device that received FDA 510(k) clearance on 2012-12-19. The listed applicant is Foundry Newcoxi, Inc.. The 510(k) number is K122954.

When did CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 receive FDA 510(k) clearance?

CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 received FDA 510(k) clearance on 2012-12-19, under 510(k) number K122954.

Who is the listed applicant for CINCHER-2.6 SUTURE ANCHOR MODEL FG-001?

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

What is the FDA product code for CINCHER-2.6 SUTURE ANCHOR MODEL FG-001?

The FDA product code for CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 is MBI.

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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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