FDA 510(k)

OES Elite Ureteroscopes and Accessories

K-Number: K200369 · 2020-08-28

Decision Date2020-08-28

Product CodeFGB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OES Elite Ureteroscopes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K200369. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OES Elite Ureteroscopes and Accessories?

OES Elite Ureteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K200369.

When did OES Elite Ureteroscopes and Accessories receive FDA 510(k) clearance?

OES Elite Ureteroscopes and Accessories received FDA 510(k) clearance on 2020-08-28, under 510(k) number K200369.

Who is the listed applicant for OES Elite Ureteroscopes and Accessories?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OES Elite Ureteroscopes and Accessories?

The FDA product code for OES Elite Ureteroscopes and Accessories is FGB.

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Other records listing Olympus Winter & Ibe GmbH as applicant

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)K221522HF-cables (resusable)K223183Light-Guide Cables K213207Sheath, Stopcock Accessory

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Related Devices (Code: FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

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.