FDA.report

510(k) K233101

Device
Luja Coude (20108 Male CH18 - large packaging)
Applicant
Coloplast Corp.
510(k) number
K233101
Product code
EZD
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-26
Date received
2023-09-26
Regulation
876.5130
Classification name
Catheter, Straight
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Troy Thome
Address
1601 W. River Rd. N. Plymouth MN US 55411 55411

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K251116Luja CoudéColoplast Corp.2025-06-27
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K250270Luja SetColoplast Corp.2025-04-17
K242049SureCath SetColoplast Corp.2024-11-26
K241210Luja CoudeColoplast Corp.2024-11-21
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