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)

Well Lead Extraction Bag

K-Number: K160801 · 2016-11-29

ApplicantWell Lead Medical Co., Ltd.
Decision Date2016-11-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Well Lead Extraction Bag 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 2016-11-29 under 510(k) 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. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K160801.

When did Well Lead Extraction Bag receive FDA 510(k) clearance?

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

Who is the listed applicant for Well Lead Extraction Bag?

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 Well Lead Extraction Bag?

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

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

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

View all 12 devices →

Related Devices (Code: GCJ)

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.

K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.K253994TroKit Laparoscope Lens WiperTroCare, LLC

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.

↑