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FDA 510(k)

CROSSFIX II MEMISCAL REPAIR DEVICE

K-Number: K121413 · 2012-06-04

ApplicantCayenne Medical, Inc.
Decision Date2012-06-04
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CROSSFIX II MEMISCAL REPAIR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2012-06-04 under 510(k) number K121413. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSFIX II MEMISCAL REPAIR DEVICE?

CROSSFIX II MEMISCAL REPAIR DEVICE is a medical device that received FDA 510(k) clearance on 2012-06-04. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K121413.

When did CROSSFIX II MEMISCAL REPAIR DEVICE receive FDA 510(k) clearance?

CROSSFIX II MEMISCAL REPAIR DEVICE received FDA 510(k) clearance on 2012-06-04, under 510(k) number K121413.

Who is the listed applicant for CROSSFIX II MEMISCAL REPAIR DEVICE?

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

What is the FDA product code for CROSSFIX II MEMISCAL REPAIR DEVICE?

The FDA product code for CROSSFIX II MEMISCAL REPAIR DEVICE is GAT.

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Other records listing Cayenne Medical, Inc. as applicant

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Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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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