Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Int…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190522

Identifiers

510(k) Number: K190522 FDA 510(k)
FDA Product Code: MQF FDA 510(k)
Models / Variants: INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter FDA 510(k)EUDAMED
CURVED and CURVED Open Tip Intra Uterine Insemination Catheter FDA 510(k)EUDAMED
TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter FDA 510(k)EUDAMED
FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter FDA 510(k)EUDAMED
STUMPY Intra Uterine Insemination Catheter FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.6110 FDA 510(k)
Regulation Number: 884.6110 FDA 510(k)
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Allwin Intra Uterine Insemination Catheters are designed for assisted reproduction procedures, specifically intrauterine insemination (IUI). These catheters facilitate the placement of sperm directly into the uterine cavity, aiding in fertility treatments by optimizing sperm deposition near the fallopian tubes.

These catheters are supplied sterile and intended for single-use. They are categorized under Class II medical devices and comply with FDA 510(k) clearance and MDR regulations. Various tip designs (open tip, curved, trackable, flexi, and stumpy) accommodate different clinical preferences and anatomical considerations. Storage and handling follow standard sterile medical device protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K190522	Class II	Active

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Manufacturer

Manufacturer: Allwin Medical Devices, Inc.

Sources (2)

FDA 510(k) K190522 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026