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)

Irrigation Tubing Bipolar Cord Set

K-Number: K251492 · 2026-06-29

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2026-06-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Irrigation Tubing Bipolar Cord Set 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 2026-06-29 under 510(k) number K251492. 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 Irrigation Tubing Bipolar Cord Set?

Irrigation Tubing Bipolar Cord Set is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K251492.

When did Irrigation Tubing Bipolar Cord Set receive FDA 510(k) clearance?

Irrigation Tubing Bipolar Cord Set received FDA 510(k) clearance on 2026-06-29, under 510(k) number K251492.

Who is the listed applicant for Irrigation Tubing Bipolar Cord Set?

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 Irrigation Tubing Bipolar Cord Set?

The FDA product code for Irrigation Tubing Bipolar Cord Set 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.

K251899E 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 CordK191064Argon Handset

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 CorporationK260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability SolutionsK253634CoolSeal Generator® (CSL-200-90)Hologic, 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.

↑