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)

New Deantronics E Green™ Electrosurgical Monopolar Pencils

K-Number: K170161 · 2017-03-29

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2017-03-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

New Deantronics E Green™ Electrosurgical Monopolar Pencils is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K170161. 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 New Deantronics E Green™ Electrosurgical Monopolar Pencils?

New Deantronics E Green™ Electrosurgical Monopolar Pencils is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K170161.

When did New Deantronics E Green™ Electrosurgical Monopolar Pencils receive FDA 510(k) clearance?

New Deantronics E Green™ Electrosurgical Monopolar Pencils received FDA 510(k) clearance on 2017-03-29, under 510(k) number K170161.

Who is the listed applicant for New Deantronics E Green™ Electrosurgical Monopolar Pencils?

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

What is the FDA product code for New Deantronics E Green™ Electrosurgical Monopolar Pencils?

The FDA product code for New Deantronics E Green™ Electrosurgical Monopolar Pencils is GEI.

Other records listing New Deantronics Taiwan , 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.

K251492Irrigation Tubing Bipolar Cord SetK251899E BlatorK202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ftK201221Electrosurgical GeneratorK200455Trigger Switch and CordK193004Monopolar Cord

View all 12 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.

↑