Endoscopic Anastomosis Clip|Ningbo SensCure Biotechnology Co., Ltd..

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Endoscopic Anastomosis Clip

The first Endoscopic Anastomosis Clip has been approved by three types of medical devices registration and CE marked for commercialization.

Operating procedure

[Specification]

The SI241 series products contain the releaser, the applicator cap, the anastomosis clip, the wire hook and the protector cap.

The SI244 series products are supplementary package for extra applicator cap with anastomosis clip.

Table 1 Specifications and Basic Sizes of Applicator Cap with Anastomosis Clip (Unit: mm)

Applicator cap specification	Max outer diameter	Tissue chamber depth	Matched endoscope tip diameter	Closure scope
1506	15.5	6	8~10.2	0~15
1508		8
1706	17	6	8.5~11	0~20
1710		10
1906	19	6	10~13	0~25
1912		12
2106	21	6	12~14	0~30
2114		14

Table 2 Specifications of the Anastomosis Clips (Unit: mm)

Anastomosis Clip Model	Closure Width	Teeth Type
A08	7.6	Type A: Short sharp teeth
B08		Type B: Long sharp teeth
C08		Type C: Blunt teeth
D08		Type D: Lateral sharp teeth
A09	8.6	Type A: Short sharp teeth
B09		Type B: Long sharp teeth
C09		Type C: Blunt teeth
D09		Type D: Lateral sharp teeth
A10	9.6	Type A: Short sharp teeth
B10		Type B: Long sharp teeth
C10		Type C: Blunt teeth
D10		Type D: Lateral sharp teeth
A11	10.6	Type A: Short sharp teeth
B11		Type B: Long sharp teeth
C11		Type C: Blunt teeth
D11		Type D: Lateral sharp teeth

Table 3 Components of the SI241 Series Products

Model	Composition					Matched endoscope tip diameter (mm)
Model	Releaser	Applicator cap	Anastomosis clip	Wire hook	Protector cap	Matched endoscope tip diameter (mm)
SI241-1506-A08	1 piece of SFQ	1 piece of 1506	1 piece of A08	2 pieces of XG	1 piece of BHM-17	8~10.2
SI241-1506-B08			1 piece of B08
SI241-1506-C08			1 piece of C08
SI241-1506-D08			1 piece of D08
SI241-1508-A08		1 piece of 1508	1 piece of A08
SI241-1508-B08			1 piece of B08
SI241-1508-C08			1 piece of C08
SI241-1508-D08			1 piece of D08
SI241-1706-A09		1 piece of 1706	1 piece of A09			8.5~11
SI241-1706-B09			1 piece of B09
SI241-1706-C09			1 piece of C09
SI241-1706-D09			1 piece of D09
SI241-1710-A09		1 piece of 1710	1 piece of A09
SI241-1710-B09			1 piece of B09
SI241-1710-C09			1 piece of C09
SI241-1710-D09			1 piece of D09
SI241-1906-A10		1 piece of 1906	1 piece of A10			10~13
SI241-1906-B10			1 piece of B10
SI241-1906-C10			1 piece of C10
SI241-1906-D10			1 piece of D10
SI241-1912-A10		1 piece of 1912	1 piece of A10
SI241-1912-B10			1 piece of B10
SI241-1912-C10			1 piece of C10
SI241-1912-D10			1 piece of D10
SI241-2106-A11		1 piece of 2106	1 piece of A11			12~14
SI241-2106-B11			1 piece of B11
SI241-2106-C11			1 piece of C11
SI241-2106-D11			1 piece of D11
SI241-2114-A11		1 piece of 2114	1 piece of A11
SI241-2114-B11			1 piece of B11
SI241-2114-C11			1 piece of C11
SI241-2114-D11			1 piece of D11

Table 4 Components of the SI244 Series Products

Model	Composition		Matched endoscope tip diameter (mm)
Model	Applicator cap	Anastomosis clip	Matched endoscope tip diameter (mm)
SI244-1506-A08	1 piece of 1506	1 piece of A08	8~10.2
SI244-1506-B08		1 piece of B08
SI244-1506-C08		1 piece of C08
SI244-1506-D08		1 piece of D08
SI244-1508-A08	1 piece of 1508	1 piece of A08
SI244-1508-B08		1 piece of B08
SI244-1508-C08		1 piece of C08
SI244-1508-D08		1 piece of D08
SI244-1706-A09	1 piece of 1706	1 piece of A09	8.5~11
SI244-1706-B09		1 piece of B09
SI244-1706-C09		1 piece of C09
SI244-1706-D09		1 piece of D09
SI244-1710-A09	1 piece of 1710	1 piece of A09
SI244-1710-B09		1 piece of B09
SI244-1710-C09		1 piece of C09
SI244-1710-D09		1 piece of D09
SI244-1906-A10	1 piece of 1906	1 piece of A10	10~13
SI244-1906-B10		1 piece of B10
SI244-1906-C10		1 piece of C10
SI244-1906-D10		1 piece of D10
SI244-1912-A10	1 piece of 1912	1 piece of A10
SI244-1912-B10		1 piece of B10
SI244-1912-C10		1 piece of C10
SI244-1912-D10		1 piece of D10
SI244-2106-A11	1 piece of 2106	1 piece of A11	12~14
SI244-2106-B11		1 piece of B11
SI244-2106-C11		1 piece of C11
SI244-2106-D11		1 piece of D11
SI244-2114-A11	1 piece of 2114	1 piece of A11
SI244-2114-B11		1 piece of B11
SI244-2114-C11		1 piece of C11
SI244-2114-D11		1 piece of D11

Table 5 Compatibility Chart

Model	Applicator cap specification	Matched endoscope tip diameter of applicator cap	Matched Supplementary Package	Protector cap specification	Matched endoscope tip diameter of protector cap
SI241-1506-A08	1506	8~10.2	SI244-1506-A08 SI244-1506-B08 SI244-1506-C08 SI244-1506-D08	BHM-17	9~12
SI241-1506-B08
SI241-1506-C08
SI241-1506-D08
SI241-1508-A08	1508		SI244-1508-A08 SI244-1508-B08 SI244-1508-C08 SI244-1508-D08
SI241-1508-B08
SI241-1508-C08
SI241-1508-D08
SI241-1706-A09	1706	8.5~11	SI244-1706-A09 SI244-1706-B09 SI244-1706-C09 SI244-1706-D09
SI241-1706-B09
SI241-1706-C09
SI241-1706-D09
SI241-1710-A09	1710		SI244-1710-A09 SI244-1710-B09 SI244-1710-C09 SI244-1710-D09
SI241-1710-B09
SI241-1710-C09
SI241-1710-D09
SI241-1906-A10	1906	10~13	SI244-1906-A10 SI244-1906-B10 SI244-1906-C10 SI244-1906-D10
SI241-1906-B10
SI241-1906-C10
SI241-1906-D10
SI241-1912-A10	1912		SI244-1912-A10 SI244-1912-B10 SI244-1912-C10 SI244-1912-D10
SI241-1912-B10
SI241-1912-C10
SI241-1912-D10
SI241-2106-A11	2106	12~14	SI241-2106-A11 SI241-2106-B11 SI241-2106-C11 SI241-2106-D11
SI241-2106-B11
SI241-2106-C11
SI241-2106-D11
SI241-2114-A11	2114		SI241-2114-A11 SI241-2114-B11 SI241-2114-C11 SI241-2114-D11
SI241-2114-B11
SI241-2114-C11
SI241-2114-D11

[Warnings]

1. Please carefully read all instructions prior to use. Do not exceed the product indications to use.

2. Please carefully examine the integrity of the sterile package prior to use. Do not use the product if the sterile package is damaged.

3. The validity of the product is three years, prohibit using the expired product.

4. This product is disposable and single use only.

5. After use, the product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state and federal laws and regulations related to product contamination by blood.

[Precautions]

1. It is recommended to apply some lubricants to the applicator cap outer surface before deploy it into patients.

2. Mount the protector cap to capture the separated clip to avoid tissue scratch.

3. Based on clinical trials, 8.8% (9/102) of the clips can spontaneously fall off within 30 days.

4. Endoscopic follow-up is mandatory within 30 days. If the clip cannot spontaneously fall off within 30 days, it need to be removed from the body by endoscopic method.

CAUTION:Indications, contraindications, warnings and instructions for use can be found in the product IFU supplied with each device. Information for use only in countries with applicable health authority registrations. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.