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FDA 510(k)

ClearPetra Suction-Evacuation Sheath

K-Number: K203119 · 2020-12-09

ApplicantWell Lead Medical Co., Ltd.
Decision Date2020-12-09
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearPetra Suction-Evacuation Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-09 under 510(k) number K203119. 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 ClearPetra Suction-Evacuation Sheath?

ClearPetra Suction-Evacuation Sheath is a medical device that received FDA 510(k) clearance on 2020-12-09. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K203119.

When did ClearPetra Suction-Evacuation Sheath receive FDA 510(k) clearance?

ClearPetra Suction-Evacuation Sheath received FDA 510(k) clearance on 2020-12-09, under 510(k) number K203119.

Who is the listed applicant for ClearPetra Suction-Evacuation Sheath?

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

What is the FDA product code for ClearPetra Suction-Evacuation Sheath?

The FDA product code for ClearPetra Suction-Evacuation 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.

NCT07072598Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URSRECRUITINGNCT07087977HoYAG vs TFL in miniPCNL With ClearPetraRECRUITING

Other records listing Well Lead Medical Co., Ltd. as applicant

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K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactK220722PVC Hydrophilic Urethral CatheterK220036Wellead Ureteral CatheterK211543Wei Nasal Jet TubeK211814Wellead Endoscopic SealK202134Well Lead All Silicone Foley Catheter with Temperature Sensor

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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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