GEM
K-Number: K213385 · 2022-07-01
ApplicantObsidio, Inc.
Decision Date2022-07-01
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
GEM is the device name listed in this FDA 510(k) record. The listed applicant is Obsidio, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213385. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GEM?
GEM is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Obsidio, Inc.. The 510(k) number is K213385.
When did GEM receive FDA 510(k) clearance?
GEM received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213385.
Who is the listed applicant for GEM?
The FDA 510(k) record lists Obsidio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GEM?
The FDA product code for GEM is KRD.
Related Devices (Code: KRD)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.
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.