FDA 510(k) Applications Submitted by COLOPLAST CORP.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K121457 |
05/16/2012 |
SPEEDICATH COMPACT SET (12 FR) |
COLOPLAST CORP. |
| K022416 |
07/24/2002 |
CONTREET FOAM ADHESIVE/NON-ADHESIVE |
COLOPLAST CORP. |
| K052229 |
08/16/2005 |
COLOPLAST OSTOMY ROD, MODEL 12814 |
COLOPLAST CORP. |
| K023254 |
09/30/2002 |
SPEEDICATH |
COLOPLAST CORP. |
| K033869 |
12/12/2003 |
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) |
COLOPLAST CORP. |
| K991202 |
03/22/1999 |
MODIFICATION TO WOUN'DRES |
COLOPLAST CORP. |
| K983042 |
08/31/1998 |
SWEEN WOUN'DRES |
COLOPLAST CORP. |
| K013525 |
10/23/2001 |
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) |
COLOPLAST CORP. |
| K242173 |
07/24/2024 |
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) |
Coloplast Corp. |
| K231953 |
06/30/2023 |
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm |
Coloplast Corp. |
| K983163 |
09/10/1998 |
BIATAIN FOAM DRESSING |
COLOPLAST CORP. |
| K983173 |
09/10/1998 |
BIATAIN FOAM ADHESIVE DRESSING |
COLOPLAST CORP. |
| K983519 |
10/08/1998 |
COMFEEL SEASORB DRESSING |
COLOPLAST CORP. |
| K122968 |
09/25/2012 |
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 |
COLOPLAST CORP. |
| K161672 |
06/09/2016 |
SpeediCath Flex Coude |
Coloplast Corp. |
| K072808 |
10/01/2007 |
SPEEDICATH COMPACT |
COLOPLAST CORP. |
| K971597 |
05/01/1997 |
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) |
COLOPLAST CORP. |
| K982493 |
07/17/1998 |
COMPEED PSORIASIS DRESSING |
COLOPLAST CORP. |
| K973070 |
08/18/1997 |
CONVEEN EASICATH SET |
COLOPLAST CORP. |
| K132061 |
07/03/2013 |
RESTORELLE M, RESTORELLE XL |
COLOPLAST CORP. |
| K122440 |
08/10/2012 |
RESTORELLE L |
COLOPLAST CORP. |
| K112386 |
08/18/2011 |
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM |
COLOPLAST CORP. |
| K251116 |
04/11/2025 |
Luja CoudΘ |
Coloplast Corp. |
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