Question 1

What types of medical devices does Takayama Instruments Inc. manufacture?

Accepted Answer

Takayama Instruments Inc. specializes in reusable surgical instruments, including forceps for manipulating soft tissue, needle holders for suturing, irrigation/aspiration cannulas and handpieces, general-purpose surgical scissors, craniofacial rongeurs, and open-surgery dissectors. These tools are designed for general surgical applications, with specific product lines like the Super Bypass and Kamiyama series. The company also produces irrigation system nozzles for surgical procedures.

Question 2

Where is Takayama Instruments Inc. based?

Accepted Answer

Takayama Instruments Inc. is headquartered in the United States. The company operates within the regulatory framework of the country, ensuring compliance with applicable standards for reusable surgical instruments.

Question 3

Which regulatory registries list Takayama Instruments Inc.’s devices?

Accepted Answer

Takayama Instruments Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are Takayama Instruments Inc.’s devices classified under US regulations?

Accepted Answer

All devices manufactured by Takayama Instruments Inc. fall under Class I regulation in the US. This classification applies to low-risk surgical instruments, including reusable tools like forceps, scissors, and irrigation systems, which are generally considered safe and effective with minimal regulatory oversight beyond basic manufacturing controls.

Device	Model / Reference	Registries	Class	Status
Kamiyama	TK-20BR	FDA UDI	Class I	Active
St	ST-T1	FDA UDI	Class I	Active
Kamiyama	KTP-120	FDA UDI	Class I	Active
Super Bypass	SBTi-70N-60-S	FDA UDI	Class I	Active
Kamiyama	K-803	FDA UDI	Class I	Active
Kamiyama	IK-1520	FDA UDI	Class I	Active
Super Bypass	SSTi-01-18020	FDA UDI	Class I	Active
Super Bypass	SSTi-01-13015	FDA UDI	Class I	Active
Super Bypass	SBTi-110N-60	FDA UDI	Class I	Active
iON	iON-90	FDA UDI	Class I	Active
Kamiyama	K-801	FDA UDI	Class I	Active
Kamiyama	KP-P03	FDA UDI	Class I	Active
Kamiyama	MT-15-S	FDA UDI	Class I	Active
Super Bypass	SB-1210-MTL	FDA UDI	Class I	Active
Kamiyama	KP-S01-18	FDA UDI	Class I	Active
St	ST-S1	FDA UDI	Class I	Active
Super Bypass	SBTi-90N-60-S	FDA UDI	Class I	Active
Kamiyama	MT-15-C30	FDA UDI	Class I	Active
Kamiyama	KP-S01	FDA UDI	Class I	Active
Kamiyama	KP-P01	FDA UDI	Class I	Active
Super Bypass	SSTi-030	FDA UDI	Class I	Active
Kw	KW-90MF	FDA UDI	Class I	Active
Kamiyama	KP-P01JFM	FDA UDI	Class I	Active
St	ST-L1	FDA UDI	Class I	Active
Super Bypass	SBTi-110N-45	FDA UDI	Class I	Active
Kamiyama	K-2010	FDA UDI	Class I	Active
Super Bypass	SSTi-01-11020	FDA UDI	Class I	Active
Kamiyama	KTP-230	FDA UDI	Class I	Active
Super Bypass	SBTi-1210	FDA UDI	Class I	Active

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