Parcus GFS BTB
K-Number: K183331 · 2019-02-07
ApplicantParcus Medical, LLC
Decision Date2019-02-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Parcus GFS BTB is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-02-07 under approval number K183331. 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 Parcus GFS BTB?
Parcus GFS BTB is a medical device that received FDA 510(k) clearance on 2019-02-07. It is manufactured by Parcus Medical, LLC. The 510(k) number is K183331.
When was Parcus GFS BTB approved by the FDA?
Parcus GFS BTB received FDA 510(k) clearance on 2019-02-07, under approval number K183331.
What company makes Parcus GFS BTB?
Parcus GFS BTB is manufactured by Parcus Medical, LLC.
What is the FDA product code for Parcus GFS BTB?
The FDA product code for Parcus GFS BTB is MBI.
Other Devices by Parcus Medical, LLC
Related Devices (Code: MBI)
K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.
K162198GFS UltimateParcus Medical, LLC
K162386KATOR Suture AnchorKator, LLC
K161033AFX Femoral Implant With InserterCayenne Medical, Inc.
K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC
K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL
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.