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FDA 510(k)

Disposable Endoscopic Trocar

K-Number: K180208 · 2018-04-09

ApplicantFengh Medical Co., Ltd.
Decision Date2018-04-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Trocar is a medical device manufactured by Fengh Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-04-09 under approval number K180208. 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 Disposable Endoscopic Trocar?

Disposable Endoscopic Trocar is a medical device that received FDA 510(k) clearance on 2018-04-09. It is manufactured by Fengh Medical Co., Ltd.. The 510(k) number is K180208.

When was Disposable Endoscopic Trocar approved by the FDA?

Disposable Endoscopic Trocar received FDA 510(k) clearance on 2018-04-09, under approval number K180208.

What company makes Disposable Endoscopic Trocar?

Disposable Endoscopic Trocar is manufactured by Fengh Medical Co., Ltd..

What is the FDA product code for Disposable Endoscopic Trocar?

The FDA product code for Disposable Endoscopic Trocar is GCJ.

Other Devices by Fengh Medical Co., Ltd.

K182476Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads K202467Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads K242679Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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