Medical Device Manufacturer · US , Mchenry , IL

Coloplast A/S

71 submissions · 68 cleared · Since 1983
71
Total
68
Cleared
0
Denied

Coloplast A/S — FDA 510(k) Submissions

Coloplast A/S has submitted 71 FDA 510(k) premarket notifications since 1983, of which 68 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Collector, Ostomy, Dressing, Wound, Drug, Bandage, Liquid, Collector, Urine, (and Accessories) For Indwelling Catheter, Tubes, Gastrointestinal (and Accessories) . Use the specialty filter in the sidebar to narrow results.

71 devices
1–25 of 71
Altis Single Incision Sling System
K221874 · PAH Mesh, Surgical,... · Gastroenterology & Urology
Feb 2023 232d
Saffron Fixation System
K220420 · PBQ Fixation, Non-absorbable... · Obstetrics & Gynecology
Jun 2022 116d
Biatain Silicone Ag
K191536 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Feb 2020 256d
ReTrace Ureteral Access Sheath
K181811 · FED Endoscopic Access... · Gastroenterology & Urology
Sep 2018 63d
Digitex Delivery Device
K173527 · PWI Instrumentation, Surgical... · Obstetrics & Gynecology
Feb 2018 90d
Peristeen Anal Irrigation System
K140310 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Sep 2015 573d
SpeediCath Compact Eve
K150935 · GBM Catheter, Urethral · Gastroenterology & Urology
Jul 2015 86d
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
K150927 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
May 2015 51d
Speedicath Compact Male
K143182 · GBM Catheter, Urethral · Gastroenterology & Urology
Jan 2015 76d
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
K140523 · FED Endoscopic Access... · Gastroenterology & Urology
Jul 2014 142d
RESTORELLE Y CONTOUR MESH
K140116 · OTO Mesh, Surgical,... · Obstetrics & Gynecology
Feb 2014 27d
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
K131072 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
Jul 2013 83d
RESTORELLE Y CONTOUR
K123914 · OTO Mesh, Surgical,... · Obstetrics & Gynecology
Mar 2013 76d
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
K123675 · FED Endoscopic Access... · Gastroenterology & Urology
Mar 2013 91d
ALTIS SINGLE INCISION CLING SYSTEM
K121562 · PAH Mesh, Surgical,... · Gastroenterology & Urology
Nov 2012 160d
SPEEDICATH COMPACT SET (12/18 FR)
K121458 · GBM Catheter, Urethral · Gastroenterology & Urology
Oct 2012 138d
OSTOMY IRRIGATION SET
K121833 · EXD Irrigator, Ostomy · Gastroenterology & Urology
Jul 2012 24d
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
K112860 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jun 2012 252d
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · NEW Suture, Surgical,... · General & Plastic Surgery
May 2012 113d
RESTORELLE POLYPROPYLENE Y MESH
K112322 · OTO Mesh, Surgical,... · Obstetrics & Gynecology
May 2012 279d
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Apr 2012 17d
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
K113496 · OTM Mesh, Surgical, For... · Gastroenterology & Urology
Feb 2012 81d
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
K111881 · OTM Mesh, Surgical, For... · General Hospital
Aug 2011 47d
SUPRIS RETROPUBIC SLING SYSTEM
K111233 · OTN Mesh, Surgical,... · Gastroenterology & Urology
Jun 2011 53d
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
K103254 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jan 2011 89d
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