Standard Trocar
K-Number: K200517 · 2020-04-09
ApplicantStandard Bariatrics
Decision Date2020-04-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Standard Trocar is a medical device manufactured by Standard Bariatrics. It received FDA 510(k) clearance on 2020-04-09 under approval number K200517. 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 Standard Trocar?
Standard Trocar is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Standard Bariatrics. The 510(k) number is K200517.
When was Standard Trocar approved by the FDA?
Standard Trocar received FDA 510(k) clearance on 2020-04-09, under approval number K200517.
What company makes Standard Trocar?
Standard Trocar is manufactured by Standard Bariatrics.
What is the FDA product code for Standard Trocar?
The FDA product code for Standard Trocar is GCJ.
Other Devices by Standard Bariatrics
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.