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FDA 510(k)

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)

K-Number: K233113 · 2023-10-25

ApplicantStarmed Co., Ltd.
Decision Date2023-10-25
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) 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 2023-10-25 under 510(k) number K233113. 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 (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)?

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K233113.

When did ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) receive FDA 510(k) clearance?

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) received FDA 510(k) clearance on 2023-10-25, under 510(k) number K233113.

Who is the listed applicant for ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)?

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 (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)?

The FDA product code for ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) 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 SystemK251566TS-RF Generator (STS10)K234140VIVA combo RF System (VIVA combo RF System)K222997VVR Generator systemK203795Star RF Electrode, VIVA RF ElectrodeK181758ELRA Electrode

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Related Devices (Code: KNS)

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.

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 CorporationK250945Single 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 CorporationK251104SureTome™ 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.

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