FDA 510(k)

Well Lead Extraction Bag

K-Number: K160801 · 2016-11-29

Decision Date2016-11-29

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Well Lead Extraction Bag is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-29 under approval number K160801. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Well Lead Extraction Bag?

Well Lead Extraction Bag is a medical device that received FDA 510(k) clearance on 2016-11-29. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K160801.

When was Well Lead Extraction Bag approved by the FDA?

Well Lead Extraction Bag received FDA 510(k) clearance on 2016-11-29, under approval number K160801.

What company makes Well Lead Extraction Bag?

Well Lead Extraction Bag is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Well Lead Extraction Bag?

The FDA product code for Well Lead Extraction Bag is GCJ.

Other Devices by Well Lead Medical Co., Ltd.

K161110ClearPetra Suction-Evacuation Sheath 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

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Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien K162059EZEE RETRIEVALGenicon, Inc.

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.