Question 1

What types of medical devices does Sewoon Medical Co., Ltd. manufacture?

Accepted Answer

Sewoon Medical Co., Ltd. designs and produces a range of medical devices, including polymer-metal stents for the trachea, bronchus, and esophagus, as well as bare-metal biliary stents. Their portfolio also includes closed-wound drainage kits, indwelling urethral drainage balloon catheters (both standard and temperature-monitoring variants), and ethanol-based rapid spectrophotometry kits for intravenous diagnostics. These devices address respiratory, biliary, urological, and diagnostic needs.

Question 2

Where is Sewoon Medical Co., Ltd. based, and how does this affect its regulatory compliance?

Accepted Answer

Sewoon Medical Co., Ltd. has a presence in the United States, meaning its devices must comply with FDA regulations. The company’s products are classified under FDA categories, including Class I and Class II, and are registered via FDA 510(k) submissions and UDI (Unique Device Identification) listings. This ensures traceability and adherence to domestic medical device standards.

Question 3

Which regulatory registries or databases list Sewoon Medical Co., Ltd.’s devices?

Accepted Answer

Sewoon Medical Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s UDI (Unique Device Identification) registry. These registries confirm the device’s classification, compliance status, and identification details, ensuring transparency for healthcare providers and regulators.

Question 4

How are Sewoon Medical Co., Ltd.’s devices classified under regulatory frameworks?

Accepted Answer

Sewoon Medical Co., Ltd.’s devices fall into two primary FDA classifications: Class I (generally low-risk devices) and Class II (devices requiring special controls to ensure safety and effectiveness). Classification depends on factors like intended use, risk level, and regulatory history, with stents and drainage systems often falling into Class II due to their clinical impact and potential risks.

Question 5

What distinguishes Sewoon Medical Co., Ltd.’s urethral drainage catheters from other similar products?

Accepted Answer

Sewoon Medical Co., Ltd. offers both standard indwelling urethral drainage balloon catheters and specialized variants with temperature-monitoring capabilities. The temperature-sensing catheters provide real-time urinary tract temperature data, which can aid in clinical assessments like urinary tract infections or kidney function monitoring. This differentiation supports precision in patient care beyond basic drainage.

Device	Model / Reference	Registries	Class	Status
BONASTENT® Tracheal/Bronchial	BTB-081012	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2103-026	FDA UDI	Class II	Active
BONASTENT® Esophageal	BER-1808	FDA UDI	Class II	Active
BONASTENT® Esophageal	BER-1816	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2101-506	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140505	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-071512	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2102-018	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100M(3.2)	FDA UDI	Class I	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L(4.8)	FDA UDI	Class I	Active
BONASTENT® Biliary	BB-080518	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-160809	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2102-022	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140705	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140509	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2102-520	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400M(3.2)N273	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-200609	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180705	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200M(3.2)S	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-200805	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100JP(4.8)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-200509	FDA UDI	Class II	Active
BONASTENT® Esophageal	BE-1808	FDA UDI	Class II	Active
BONASTENT® Biliary	BB-080818	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-120505	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200M+(3.2)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-180509	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS400XL+ 24fr	FDA UDI	Class I	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400M(3.2)N2	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-160305	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-160609	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-160505	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140605	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS250M(3.2)	FDA UDI	Class I	Active
BONASTENT® Tracheal/Bronchial	BTB-200605	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-140309	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-100505	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180309	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-200709	FDA UDI	Class II	Active
All Silicone Foley Balloon Catheter	2102-518	FDA UDI	Class II	Active
Temperature Sensing Foley Balloon Catheter	2105-008	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-200309	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100M(3.2)S	FDA UDI	Class I	Active
All Silicone Foley Balloon Catheter	2103-022	FDA UDI	Class II	Active
BONASTENT® Tracheal/Bronchial	BTB-180305	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS250L(4.8)	FDA UDI	Class I	Active
BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L(4.8)S	FDA UDI	Class I	Active
BONASTENT® Esophageal	BER-1812	FDA UDI	Class II	Active
BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400L(4.8)	FDA UDI	Class I	Active

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