Atlas FDA

INTRAUTERINE INSEMINATION (IUI) CATHETER

FDA 510(k) clearance K092579 · decided 2010-04-02

Clearance details

K-number
K092579
Device name
INTRAUTERINE INSEMINATION (IUI) CATHETER
Applicant
Fertiligent, Ltd.
Decision
Substantially Equivalent
Date received
2009-08-17
Decision date
2010-04-02
Days to decision
228 days
Clearance type
Traditional
Product code
MQF
Device class
2
Regulation number
884.6110
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.