FDA 510(k)

Optimos™ Cystotome

K-Number: K223256 · 2023-04-05

Decision Date2023-04-05

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Optimos™ Cystotome is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K223256. 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 Optimos™ Cystotome?

Optimos™ Cystotome is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223256.

When did Optimos™ Cystotome receive FDA 510(k) clearance?

Optimos™ Cystotome received FDA 510(k) clearance on 2023-04-05, under 510(k) number K223256.

Who is the listed applicant for Optimos™ Cystotome?

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

What is the FDA product code for Optimos™ Cystotome?

The FDA product code for Optimos™ Cystotome is KNS.

Other records listing Taewoong Medical 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.

K260962Sphincterotome K252648Niti-S SPAXUS Stent K251123Niti-S Biliary Stent; Niti-S Biliary Slim M Stent K243619Niti-S Esophageal Stent; Esophageal TTS Stent K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent K240522Esophageal TTS Stent

View all 12 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.