Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tixel® 2 System

K-Number: K223033 · 2023-06-21

ApplicantNovoxel , Ltd.
Decision Date2023-06-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tixel® 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Novoxel , Ltd.. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K223033. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tixel® 2 System?

Tixel® 2 System is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Novoxel , Ltd.. The 510(k) number is K223033.

When did Tixel® 2 System receive FDA 510(k) clearance?

Tixel® 2 System received FDA 510(k) clearance on 2023-06-21, under 510(k) number K223033.

Who is the listed applicant for Tixel® 2 System?

The FDA 510(k) record lists Novoxel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tixel® 2 System?

The FDA product code for Tixel® 2 System is GEI.

Other records listing Novoxel , Ltd. as applicant

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.

K240512Tixel i (TXLI0001)K202988Tixel System

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑