SpeediCath Flex Set

510(k) Number

K222059 ↗

FDA product code

EZD

Device class

Class II

Regulation

21 CFR Part 876.5130

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EZD (Catheter, Straight).

• AMSure® PVC Intermittent Catheter 1 AS860606 by AMSINO INTERNATIONAL, INC.
• AMSure® PVC Intermittent Catheter 1 AS861614 by AMSINO INTERNATIONAL, INC.
• 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) by Hollister Incorporated
• Magic3 Go Intermittent Urinary Catheter by C. R. Bard, Inc.
• EXPRESSWAY INTERMITTENT CATHETER by Percutaneous Systems, Incorporated
• EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits by HR HealthCare
• Cure Catheter Closed System; Cure Dextra Closed System by Convatec, Ltd.
• LoFric Elle Pro by Wellspect AB
• DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC by Dynarex Corp.
• COMFORTGLIDE INTERMITENT CATHETER by C. R. Bard, Inc.

• Manhood 27-4200-B / 50710

  Class I

  GUDID on market

• InterDry 7915

  Class I

  FDA 510(k) K110715 Active Cleared 4 Nov 2011 GUDID on market

• InterDry 7910

  Class I

  FDA 510(k) K110715 Active Cleared 4 Nov 2011 GUDID on market

• InterDry 7912

  Class I

  FDA 510(k) K110715 Active Cleared 4 Nov 2011 GUDID on market

See all devices from Coloplast Corp. →