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510(k) Data Aggregation
K Number
K232216Device Name
Hemoblock_S (Prescription); Hemoblock_S (OTC)
Manufacturer
Incore Co., Ltd.
Date Cleared
2024-04-19
(268 days)
Product Code
QSY, OSY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Incore Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations
Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions
Device Description
The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market.
Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following;
- Gauze(N) Type: There is not strap yarn part on the Hemoblock_S
- Gauze(S) Type: There is strap yarn part on the Hemoblock_S
The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.
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K Number
K221054Device Name
CORE-INJECTOR
Manufacturer
Incore Co., Ltd.
Date Cleared
2022-12-21
(254 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Incore Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
Device Description
The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure. The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm. The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
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K Number
K220846Device Name
CORE-SNARE
Manufacturer
Incore Co., Ltd.
Date Cleared
2022-11-21
(243 days)
Product Code
FDI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Incore Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORE-SNARE is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
Device Description
The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures. The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths. Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
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K Number
K220081Device Name
CORE-SPORT
Manufacturer
Incore Co., Ltd.
Date Cleared
2022-09-28
(261 days)
Product Code
OTJ, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Incore Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
Device Description
The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.
Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.
The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.
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K Number
K213338Device Name
CORE-CLIP
Manufacturer
Incore Co., Ltd.
Date Cleared
2022-06-23
(259 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Incore Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects < 3cm
(b) Bleeding ulcers
(c) Arteries < 2 mm
(d) Polyps < 1.5 cm in diameter
(e) Diverticula in the colon
(3) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
Device Description
The endoscope clip is a metallic mechanical device used in endoscopy in order to close two mucosal surfaces without the need for surgery and suturing. Its function is similar to a suture in gross surgical applications, as it is used to join together two disjointed surfaces, but, can be applied through the channel of an endoscope under direct visualization. The endoscope clip has found use in treating gastrointestinal bleeding (both in the upper and lower GI tract), in preventing bleeding after therapeutic procedures such as polypectomy, and in closing gastrointestinal perforations.
The Handle Slider and the coil are connected, and the clip are connected. When the Handle Slider is moved backward, the coil connected to the Handle Slider is pulled back, and the clip is also pulled back and the clip is closed as the clip enters the Clip Body. After the clip is completely closed, the clip will no longer be pulled back and when the threshold is reached, the Disconnection connector part will eventually break. As a result, the delivery device and the clip are completely separated, and the clip remains alone to maintain hemostasis.
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K Number
K211148Device Name
CORE-Trocar
Manufacturer
Incore CO., LTD.
Date Cleared
2022-06-21
(428 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Incore CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.
Device Description
The CORE-Trocar has a port to insert endoscopic instruments during endoscopic procedures. It consist of a cannula and a obturator. The Trocar is available in nine (9) models(IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) and the models are divided into six (6) types according to the kinds of diameter Type : 2mm Type(IC-TC02, IC-TC02S), 3mm Type(IC-TC03, IC-TC03S), 5mm Type(IC-TC05, IC-TC05S), 8mm Type(IC-TC08), 10mm Type(IC-TC10) and 12mm Type(IC-TC12). The cannula assembly have seals(main, secondary), a valve and a stopcock. The obturator has non-bladed tip. Sterilization is done with EO gas and Sterilization Assurance Level(SAL) 10-6. The seals prevent loss of CO2 pneumoperitoneum pressure when instruments are inserted or withdrawn.
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