ClearanceBrief
Company ยท KR

Incore Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2024. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FBKEndoscopic Injection Needle, Gastroenterology-Urology1
FDISnare, Flexible1
GCJLaparoscope, General & Plastic Surgery1
OTJLaparoscopic Single Port Access Device1
PKLHemostatic Metal Clip For The Gi Tract1
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 19, 2024K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)
Incore Co., Ltd., KR
QSY
Dec 21, 2022K221054CORE-INJECTOR
Incore Co., Ltd., KR
FBK
Nov 21, 2022K220846CORE-SNARE
Incore Co., Ltd., KR
FDI
Sep 28, 2022K220081CORE-SPORT
Incore Co., Ltd., KR
OTJ
Jun 23, 2022K213338CORE-CLIP
Incore Co., Ltd., KR
PKL
Jun 21, 2022K211148CORE-Trocar
Incore Co., Ltd., KR
GCJ

Latest recalls

DateFirm and productCodeLinked 510(k)
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