FDA 510(k)

RASL Repair Kit

Numéro K : K161334 · 2017-02-09

Date de décision2017-02-09

Code produitHWC

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

RASL Repair Kit is the device name listed in this FDA 510(k) record. The listed applicant is Radicle Orthopaedics, Inc.. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K161334. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the RASL Repair Kit?

RASL Repair Kit is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Radicle Orthopaedics, Inc.. The 510(k) number is K161334.

When did RASL Repair Kit receive FDA 510(k) clearance?

RASL Repair Kit received FDA 510(k) clearance on 2017-02-09, under 510(k) number K161334.

Who is the listed applicant for RASL Repair Kit?

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

What is the FDA product code for RASL Repair Kit?

The FDA product code for RASL Repair Kit is HWC. This falls under the Cardiovascular category.

Essais cliniques associés

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Source officielle

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