SpeediCath Soft

510(k) Number

K200142 ↗

FDA product code

GBM

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 GBM (Catheter, Urethral).

• WALTHER CATHETERS, MALE, FEMALE by Thomasville Medical Assoc.
• O'Neil Intermittent Urinary Catheter 10 Gauge ONSM10 by GO MEDICAL INDUSTRIES PTY. LTD.
• Modification To: Lofric Plus Single Use Urinary Catheter by Astra Tech, Inc.
• Urinary Catheters by Promedic, Inc.
• PEDIATRIC URINARY CATHETER by Clay Kennard
• Actreen Hi-Lite Intermittent Urinary Catheters by B. Braun Medical, Inc.
• Rusch FloCath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter by Teleflex Medical, LLC
• O'Neil Intermittent Urinary Catheter 8 Gauge ONSM08 by GO MEDICAL INDUSTRIES PTY. LTD.
• Catheter, Silicone Foley (Bardex) by C. R. Bard, Inc.
• GentleCath Glide Intermittent Urinary Catheter by Convatec, Ltd.

• 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. →