FDA 510(k)

Hemoblock_S (Prescription); Hemoblock_S (OTC)

K-Number: K232216 · 2024-04-19

Decision Date2024-04-19

Product CodeQSY

DecisionSubstantially Equivalent

Device Summary

Hemoblock_S (Prescription); Hemoblock_S (OTC) is a medical device manufactured by Incore Co., Ltd.. It received FDA 510(k) clearance on 2024-04-19 under approval number K232216. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemoblock_S (Prescription); Hemoblock_S (OTC)?

Hemoblock_S (Prescription); Hemoblock_S (OTC) is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Incore Co., Ltd.. The 510(k) number is K232216.

When was Hemoblock_S (Prescription); Hemoblock_S (OTC) approved by the FDA?

Hemoblock_S (Prescription); Hemoblock_S (OTC) received FDA 510(k) clearance on 2024-04-19, under approval number K232216.

What company makes Hemoblock_S (Prescription); Hemoblock_S (OTC)?

Hemoblock_S (Prescription); Hemoblock_S (OTC) is manufactured by Incore Co., Ltd..

What is the FDA product code for Hemoblock_S (Prescription); Hemoblock_S (OTC)?

The FDA product code for Hemoblock_S (Prescription); Hemoblock_S (OTC) is QSY.

Other Devices by Incore Co., Ltd.

K221054CORE-INJECTOR K220846CORE-SNARE K220081CORE-SPORT K213338CORE-CLIP K211148CORE-Trocar

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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.