510(k) K260999

Device: LoFric Elle Pro
Applicant: Wellspect AB
510(k) number: K260999
Product code: EZD
Decision: Substantially Equivalent (SESE)
Decision date: 2026-04-24
Date received: 2026-03-26
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: N

Related Records

Applicant Contact

Contact: Emad Ramzi
Address: Amniogatan 1, P.O.Box 14 Se-431 51 Sweden Mölndal SE

FDA Registration Numbers

9617594
3014404707
1423537
2024024
3011987967
9616668
3005690789
3010400865
3003717263
3002807314
3031571464
3003974574
3005562917
2032112
9613662
1018233
1054241
1928237
3008729910
8043792
3023174629
3011707784
2029015
3023329815
1921846
3016171914
3003903031
9611590
1055236
3002993863
2953359
3008806809
3006606901
3009337401
3011020307
1061124
9612030
3005012805
3009504230
3005515211
3005945907
3006553489
3010288357
3015131144
1043214
3007007790
2030598
3006430057
3008102042
1000317571
1417592
3009632672
3008772421
3006673317
3015176887
3005941719
9610694
3014498861
2320961
1647149
3006082230
3017961114
3016761372
1480288
2032098
3004122598
3030671614
3016863553
3038139564
3006536657
3005669815
1713468
3011270181
3008262278
3006405073
3010580321
3007697249
3016675012
3015142802
3018116884

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EZD

510(k)	Device	Applicant	Decision date
K253295	Coude Sleeved IC; Coude Plus Sleeved IC	Hollister Incorporated	2026-05-18
K252943	GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women	Convatec Limited	2026-04-01
K260502	Liv Pre-lubricated Intermittent Catheter	HR Healthcare	2026-03-12
K251274	EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits	HR Healthcare	2026-01-29
K251178	Ready to use Nelaton Catheter	Jamjoom Fullcare Corporation	2026-01-02
K251468	Sleeved 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 Incorporated	2025-10-03
K250659	LoFric Origo	Wellspect AB	2025-09-26
K250699	Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)	Convatec	2025-07-01
K251116	Luja Coudé	Coloplast Corp.	2025-06-27
K243175	Disposable Intermittent Catheter (TPU Catheter)	Chengdu Daxan Innovative Medical Tech. Co., Ltd.	2025-06-26
K250270	Luja Set	Coloplast Corp.	2025-04-17
K242049	SureCath Set	Coloplast Corp.	2024-11-26
K241210	Luja Coude	Coloplast Corp.	2024-11-21
K241028	Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)	Coloplast	2024-07-26
K233524	Sleeved 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 Incorporated	2024-05-03