Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RE-TRACE URETERAL ACCESS SHEATH

K-Number: K102485 · 2010-10-18

ApplicantColoplast A/S
Decision Date2010-10-18
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RE-TRACE 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 2010-10-18 under 510(k) number K102485. 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 RE-TRACE URETERAL ACCESS SHEATH?

RE-TRACE URETERAL ACCESS SHEATH is a medical device that received FDA 510(k) clearance on 2010-10-18. The listed applicant is Coloplast A/S. The 510(k) number is K102485.

When did RE-TRACE URETERAL ACCESS SHEATH receive FDA 510(k) clearance?

RE-TRACE URETERAL ACCESS SHEATH received FDA 510(k) clearance on 2010-10-18, under 510(k) number K102485.

Who is the listed applicant for RE-TRACE 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 RE-TRACE URETERAL ACCESS SHEATH?

The FDA product code for RE-TRACE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 AgK181811ReTrace Ureteral Access SheathK173527Digitex Delivery Device

View all 66 devices →

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC 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.

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.

↑