FDA.report

510(k) K242049

Device
SureCath Set
Applicant
Coloplast Corp.
510(k) number
K242049
Product code
EZD
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-26
Date received
2024-07-12
Regulation
876.5130
Classification name
Catheter, Straight
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Vallabha Tantry
Address
1601 W. River Rd. N. Minneapolis MN US 55441 55441

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EZD

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K251178Ready to use Nelaton CatheterJamjoom Fullcare Corporation2026-01-02
K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)Hollister Incorporated2025-10-03
K250659LoFric OrigoWellspect AB2025-09-26
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K251116Luja CoudéColoplast Corp.2025-06-27
K243175Disposable Intermittent Catheter (TPU Catheter)Chengdu Daxan Innovative Medical Tech. Co., Ltd.2025-06-26
K250270Luja SetColoplast Corp.2025-04-17
K241210Luja CoudeColoplast Corp.2024-11-21
K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)Coloplast2024-07-26
K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)Hollister Incorporated2024-05-03