FDA 510(k)

ELRA Electrode

K-Number: K181758 · 2019-04-11

Decision Date2019-04-11

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ELRA Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K181758. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELRA Electrode?

ELRA Electrode is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K181758.

When did ELRA Electrode receive FDA 510(k) clearance?

ELRA Electrode received FDA 510(k) clearance on 2019-04-11, under 510(k) number K181758.

Who is the listed applicant for ELRA Electrode?

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

What is the FDA product code for ELRA Electrode?

The FDA product code for ELRA Electrode is KNS.

Other records listing Starmed Co., 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.

K252833VIVA combo RF System K251566TS-RF Generator (STS10)K234140VIVA combo RF System (VIVA combo RF System)K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)K222997VVR Generator system K203795Star RF Electrode, VIVA RF Electrode

View all 11 devices →

Related Devices (Code: KNS)

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

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.