FDA 510(k) Applications Submitted by Calen Souther

FDA 510(k) Number Submission Date Device Name Applicant
K221135 04/19/2022 X-Twist PEEK Suture Anchor Parcus Medical LLC
K232513 08/18/2023 X-Twist Biocomposite Suture Anchor Parcus Medical
K212739 08/30/2021 ActiFlip Parcus Medical LLC.
K193573 12/23/2019 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro Molnlycke Health Care US LLC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact