RASL Repair Kit
K-Number: K161334 · 2017-02-09
ApplicantRadicle Orthopaedics, Inc.
Decision Date2017-02-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
RASL Repair Kit is a medical device manufactured by Radicle Orthopaedics, Inc.. It received FDA 510(k) clearance on 2017-02-09 under approval 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.
Frequently Asked Questions
What is the RASL Repair Kit?
RASL Repair Kit is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Radicle Orthopaedics, Inc.. The 510(k) number is K161334.
When was RASL Repair Kit approved by the FDA?
RASL Repair Kit received FDA 510(k) clearance on 2017-02-09, under approval number K161334.
What company makes RASL Repair Kit?
RASL Repair Kit is manufactured by Radicle Orthopaedics, Inc..
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.
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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.