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FDA 510(k)

ReTrace Ureteral Access Sheath

K-Number: K181811 · 2018-09-07

ApplicantColoplast A/S
Decision Date2018-09-07
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ReTrace Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181811. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReTrace Ureteral Access Sheath?

ReTrace Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Coloplast A/S. The 510(k) number is K181811.

When did ReTrace Ureteral Access Sheath receive FDA 510(k) clearance?

ReTrace Ureteral Access Sheath received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181811.

Who is the listed applicant for ReTrace Ureteral Access Sheath?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReTrace Ureteral Access Sheath?

The FDA product code for ReTrace Ureteral Access Sheath is FED.

Related Clinical Trials

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.

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Other records listing Coloplast A/S 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.

K262045Luja SoftK221874Altis Single Incision Sling SystemK220420Saffron Fixation SystemK191536Biatain Silicone AgK173527Digitex Delivery Device

Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development 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.

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