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)

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

K-Number: K193356 · 2020-03-02

ApplicantCovidien, LLC
Decision Date2020-03-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K193356. 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 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Covidien, LLC. The 510(k) number is K193356.

When did BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider receive FDA 510(k) clearance?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider received FDA 510(k) clearance on 2020-03-02, under 510(k) number K193356.

Who is the listed applicant for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

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

What is the FDA product code for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

The FDA product code for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is GEI.

Other records listing Covidien, LLC 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.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)K253984Instrument Exit Point on Touch Surgery™ AideK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTK251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)K250725Hugo™ RAS System

View all 119 devices →

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.

↑