Data / Medical devices / South Korea / CnS MEDICAL CO., LTD.

CnS MEDICAL CO., LTD.: FDA-registered device maker in Pocheon-si Gyeonggi, South Korea, 1 510(k) clearance

Name: CnS MEDICAL CO., LTD. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CnS MEDICAL CO., LTD. is registered with the FDA (registration 3021519357) in Pocheon-si Gyeonggi, South Korea. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021519357
Address: 94-40 Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, Republic of Korea, Pocheon-si Gyeonggi, South Korea, 11154
Owner or operator: CnS MEDICAL Co., Ltd. (10089381)
Roles: Manufacturer
First device listed: August 5, 2024
Registered through: 2026
Brand names listed: Bone Chip Cannula & Impactor, Bone Wax Delivery Tube, CVD Dilator - MHSD-Bar, Cage Guide, Cage Guide UFG, Curette, DELPHI System, Dilator and more

Devices it lists

Device	Product code	Class	Role	Source
Bur, Surgical, General & Plastic Surgery	GFF	1	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Manufacturer	accessdata.fda.gov
Dilator, Catheter	GCC	1	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer	accessdata.fda.gov
Hammer, Surgical	FZY	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 6, 2025	K242907	DELPHI System	GEI	Substantially Equivalent	CnS Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.