PointCore Surgical Mask
K-Number: K220944 · 2022-09-09
ApplicantPointcore, Inc.
Decision Date2022-09-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PointCore Surgical Mask is a medical device manufactured by Pointcore, Inc.. It received FDA 510(k) clearance on 2022-09-09 under approval number K220944. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PointCore Surgical Mask?
PointCore Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-09. It is manufactured by Pointcore, Inc.. The 510(k) number is K220944.
When was PointCore Surgical Mask approved by the FDA?
PointCore Surgical Mask received FDA 510(k) clearance on 2022-09-09, under approval number K220944.
What company makes PointCore Surgical Mask?
PointCore Surgical Mask is manufactured by Pointcore, Inc..
What is the FDA product code for PointCore Surgical Mask?
The FDA product code for PointCore Surgical Mask is FXX.
Related Devices (Code: FXX)
K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC
K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd.
K152197Skypro, SP01 MaskSkypro Medical Supplies Company
K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd.
K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech
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.