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FDA 510(k)

ClearPetra Suction-Evacuation Sheath

K-Number: K161110 · 2016-10-12

ApplicantWell Lead Medical Co., Ltd.
Decision Date2016-10-12
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearPetra Suction-Evacuation Sheath is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-10-12 under approval number K161110. 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 2016-10-12. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K161110.

When was ClearPetra Suction-Evacuation Sheath approved by the FDA?

ClearPetra Suction-Evacuation Sheath received FDA 510(k) clearance on 2016-10-12, under approval number K161110.

What company makes ClearPetra Suction-Evacuation Sheath?

ClearPetra Suction-Evacuation Sheath is manufactured by Well Lead Medical Co., Ltd..

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

NCT06547632 ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach TERMINATED NCT07087977 HoYAG vs TFL in miniPCNL With ClearPetra RECRUITING NCT07072598 Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS RECRUITING

Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K151084Well Lead Ureteral Access Sheath K162340Stomach Tube K182739Endotracheal Tube with Evacuation Lumen K203119ClearPetra Suction-Evacuation Sheath K202134Well Lead All Silicone Foley Catheter with Temperature Sensor

View all 12 devices →

Related Devices (Code: FED)

K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. K160846AmplifEYEMedivators, Inc. K160861Proxis Ureteral Access SheathC.R. Bard, Inc. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated K181811ReTrace Ureteral Access SheathColoplast A/S

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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