FDA 510(k) Applications Submitted by Coloplast A/S
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K091152 |
04/20/2009 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 |
COLOPLAST A/S |
| K101297 |
05/10/2010 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 |
COLOPLAST A/S |
| K140523 |
03/04/2014 |
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM |
COLOPLAST A/S |
| K131072 |
04/17/2013 |
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC |
COLOPLAST A/S |
| K121458 |
05/16/2012 |
SPEEDICATH COMPACT SET (12/18 FR) |
COLOPLAST A/S |
| K102485 |
08/30/2010 |
RE-TRACE URETERAL ACCESS SHEATH |
COLOPLAST A/S |
| K112860 |
09/30/2011 |
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER |
COLOPLAST A/S |
| K103254 |
11/03/2010 |
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE |
COLOPLAST A/S |
| K143182 |
11/05/2014 |
Speedicath Compact Male |
COLOPLAST A/S |
| K123675 |
11/30/2012 |
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR |
COLOPLAST A/S |
| K181811 |
07/06/2018 |
ReTrace Ureteral Access Sheath |
Coloplast A/S |
| K220420 |
02/14/2022 |
Saffron Fixation System |
Coloplast A/S |
| K221874 |
06/28/2022 |
Altis Single Incision Sling System |
Coloplast A/S |
| K120284 |
01/31/2012 |
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX |
COLOPLAST A/S |
| K113496 |
11/25/2011 |
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT |
COLOPLAST A/S |
| K121562 |
05/29/2012 |
ALTIS SINGLE INCISION CLING SYSTEM |
COLOPLAST A/S |
| K111881 |
07/01/2011 |
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT |
COLOPLAST A/S |
| K083499 |
11/25/2008 |
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS |
COLOPLAST A/S |
| K103568 |
12/06/2010 |
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
COLOPLAST A/S |
| K083770 |
12/18/2008 |
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM |
COLOPLAST A/S |
| K191536 |
06/10/2019 |
Biatain Silicone Ag |
Coloplast A/S |
| K150927 |
04/06/2015 |
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff |
COLOPLAST A/S |
| K140310 |
02/07/2014 |
Peristeen Anal Irrigation System |
COLOPLAST A/S |
| K150935 |
04/07/2015 |
SpeediCath Compact Eve |
COLOPLAST A/S |
| K173527 |
11/14/2017 |
Digitex Delivery Device |
Coloplast A/S |
| K100218 |
01/26/2010 |
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM |
COLOPLAST A/S |
| K120828 |
03/19/2012 |
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES |
COLOPLAST A/S |
| K090217 |
01/29/2009 |
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 |
COLOPLAST A/S |
| K140116 |
01/16/2014 |
RESTORELLE Y CONTOUR MESH |
COLOPLAST A/S |
| K111233 |
05/02/2011 |
SUPRIS RETROPUBIC SLING SYSTEM |
COLOPLAST A/S |
| K121833 |
06/22/2012 |
OSTOMY IRRIGATION SET |
COLOPLAST A/S |
| K112322 |
08/12/2011 |
RESTORELLE POLYPROPYLENE Y MESH |
COLOPLAST A/S |
| K123914 |
12/19/2012 |
RESTORELLE Y CONTOUR |
COLOPLAST A/S |
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