LapBag
K-Number: K171726 · 2017-09-25
ApplicantSejong Medical Co., Ltd.
Decision Date2017-09-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
LapBag is a medical device manufactured by Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-09-25 under approval number K171726. 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 LapBag?
LapBag is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Sejong Medical Co., Ltd.. The 510(k) number is K171726.
When was LapBag approved by the FDA?
LapBag received FDA 510(k) clearance on 2017-09-25, under approval number K171726.
What company makes LapBag?
LapBag is manufactured by Sejong Medical Co., Ltd..
What is the FDA product code for LapBag?
The FDA product code for LapBag is GCJ.
Other Devices by Sejong Medical Co., Ltd.
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.