Endoscopic Irrigation/Aspiration Pumps - India CDSCO Medical Device Registration

Endoscopic Irrigation/Aspiration Pumps is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000585_30a09393b856daf7917169cd642c25d5_7e6625f56baf694af0b88644a991098c. This device is marketed under the brand name FloSteady & FloControl . The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Endoscopic Irrigation/Aspiration Pumps

UID: IMP/MD/2023/000585_30a09393b856daf7917169cd642c25d5_7e6625f56baf694af0b88644a991098c

Brand Name

FloSteady & FloControl

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class B

Approving Authority

CDSCO

Product Information

The device is an irrigation pump with a balancing system for hysteroscopies. It is used to introduce fluids into the uterine cavity. The device may not be used for other endoscopic procedures. The stand and balancing system may only be used with the accompanying pump. The device is indicated for liquid distension of the uterus for diagnostic and Indications operative hysteroscopic procedures, and monitoring the volume differential between the irrigation fluid flowing into and out of the uterus. Please comply with the specific indications and instructions provided in the manual of your endoscope