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FDA 510(k)

LapBag

K-Number: K171726 · 2017-09-25

Decision Date2017-09-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LapBag is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) 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. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K171726.

When did LapBag receive FDA 510(k) clearance?

LapBag received FDA 510(k) clearance on 2017-09-25, under 510(k) number K171726.

Who is the listed applicant for LapBag?

The FDA 510(k) record lists Sejong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LapBag?

The FDA product code for LapBag is GCJ.

Other records listing Sejong 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.

View all 9 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.

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.