Question 1

What types of medical devices does Microworld Medical Instruments, Inc. manufacture?

Accepted Answer

Microworld Medical Instruments, Inc. specializes in surgical instruments, specifically the COLIBRI disposable vitrectomy cutter. This device is designed for vitreoretinal procedures, where it is used to remove the vitreous humor from the eye during surgery. The company’s current portfolio focuses on single-use surgical tools for ophthalmic applications.

Question 2

Where is Microworld Medical Instruments, Inc. based?

Accepted Answer

Microworld Medical Instruments, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations.

Question 3

How are Microworld Medical Instruments, Inc.’s devices classified by regulatory authorities?

Accepted Answer

The COLIBRI disposable vitrectomy cutter, Microworld Medical Instruments, Inc.’s primary device, falls under FDA Class II classification. This classification is assigned based on the device’s intended use and associated risks, requiring premarket notification (510(k)) submission for authorization before commercial distribution.

Question 4

Which regulatory registries or databases list Microworld Medical Instruments, Inc.’s devices?

Accepted Answer

Microworld Medical Instruments, Inc.’s COLIBRI disposable vitrectomy cutter is listed in the FDA’s 510(k) database. This registry tracks devices authorized through the 510(k) pathway, ensuring transparency about their regulatory status and intended use.

Device	Model / Reference	Registries	Class	Status
Synaptix Plug G Type	DWS-G1J000000W	EUDAMED	Class I	Active
Micro Needle Holder Suture Cut	INS-AeT2221	EUDAMEDFDA UDI	Class IIa	Active
Synaptix Plug E Type	DWS-E1J000000W	EUDAMED	Class I	Active
CMM (Plug E Type)	CMM-E010	EUDAMED	Class IIa	Active
Colibri Disposable Vitrectomy Cutter	K033390	FDA 510(k)	Class II	Active
Symani Surgical System	K242368	FDA 510(k)	Class II	Active
Symani Surgical System	K252287	FDA 510(k)	Class II	Active
Symani Surgical System	K251510	FDA 510(k)	Class II	Active
Symani Surgical System (820-03830)	K250014	FDA 510(k)	Class II	Active
CMM (Plug G Type)	CMM-G010	EUDAMED	Class IIa	Active
CMM (Plug K Type)	CMM-K010	EUDAMED	Class IIa	Active
Instrument Dilator	INS-DbM1221	EUDAMED	Class IIa	Active
Super Micro Needle Holder	INS-NaS2221	EUDAMEDFDA UDI	Class IIa	Active
Console Flat	CNS-000	EUDAMEDFDA UDI	Class IIa	Active
Instrument Needle Holder	INS-NaM1221	EUDAMED	Class IIa	Active
Micro Needle Holder	INS-AaT2221	EUDAMEDFDA UDI	Class IIa	Active
CMM (Plug J Type)	CMM-J010	EUDAMED	Class IIa	Active
Synaptix Plug J Type	DWS-J1J000000W	EUDAMED	Class I	Active
Contoured Master Clip	ACC-220	EUDAMEDFDA UDI	Class I	Active
Synaptix Plug I Type	DWS-I1J000000W	EUDAMED	Class I	Active
Super Micro Dilator	INS-DbS1221	EUDAMEDFDA UDI	Class IIa	Active
Instrument SuperMicro Needle Holder Suture Cut	INS-NeS1221	EUDAMEDFDA UDI	Class IIa	Active
Synaptix Plug K Type	DWS-K1J000000W	EUDAMED	Class I	Active
Micro Dilator	INS-ObM1221	EUDAMEDFDA UDI	Class IIa	Active
Synaptix Plug F Type	DWS-F1J000000W	EUDAMED	Class I	Active
Instrument Connector	ACC-101	EUDAMEDFDA UDI	Class I	Active
Scissors	INS-RfM3221	EUDAMED	Class IIa	Active
CMM (Plug B Type)	CMM-B010	EUDAMEDFDA UDI	Class IIa	Active
Synaptix Plug B Type	DWS-B1J000000W	EUDAMED	Class I	Active
Console	CNS-100	EUDAMEDFDA UDI	Class IIa	Active
Master Clip	ACC-200	EUDAMEDFDA UDI	Class I	Active
Instrument Forceps	INS-PbM1221	EUDAMED	Class IIa	Active
Master Holder	ACC-300	EUDAMEDFDA UDI	Class I	Active

Microworld Medical Instruments, Inc.

What Microworld Medical Instruments, Inc. makes

Frequently asked questions

Information

Catalogue (33)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities