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FDA 510(k)

CORE-Trocar

K-Number: K211148 · 2022-06-21

ApplicantIncore Co., Ltd.
Decision Date2022-06-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE-Trocar is a medical device manufactured by Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-06-21 under approval number K211148. 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 CORE-Trocar?

CORE-Trocar is a medical device that received FDA 510(k) clearance on 2022-06-21. It is manufactured by Incore Co., Ltd.. The 510(k) number is K211148.

When was CORE-Trocar approved by the FDA?

CORE-Trocar received FDA 510(k) clearance on 2022-06-21, under approval number K211148.

What company makes CORE-Trocar?

CORE-Trocar is manufactured by Incore Co., Ltd..

What is the FDA product code for CORE-Trocar?

The FDA product code for CORE-Trocar is GCJ.

Other Devices by Incore Co., Ltd.

K221054CORE-INJECTOR K220846CORE-SNARE K220081CORE-SPORT K213338CORE-CLIP K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)

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.

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