Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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: K182451 · 2018-11-06

ApplicantCovidien, LLC
Decision Date2018-11-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2018-11-06 under approval number K182451. 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 2018-11-06. It is manufactured by Covidien, LLC. The 510(k) number is K182451.

When was BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider approved by the FDA?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider received FDA 510(k) clearance on 2018-11-06, under approval number K182451.

What company makes BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is manufactured by Covidien, LLC.

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.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT05313555 The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin TERMINATED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT02030691 Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress COMPLETED

Related PubMed Literature

PMID: 41832928 Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China. European radiology (2026) PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40833550 Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions. Drug safety (2026)

Other Devices by Covidien, LLC

K163105Emprint Ablation System K163098Tri-Staple 2.0 Intelligent Cartridge K160290Valleylab REM Polyhesive Infant Patient Return Electrode K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) K152794Cytosponge Cell Collection Device K160360Barrx FLEX RFA Energy Generator

View all 57 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑