Data / Medical devices / France / Centre de distribution Coloplast Le Plessis Pate
Centre de distribution Coloplast Le Plessis Pate: FDA-registered device maker in Le Plessis-Pate Essonne, France, 19 510(k) clearances
Centre de distribution Coloplast Le Plessis Pate is registered with the FDA (registration 3012649202) in Le Plessis-Pate Essonne, France. It lists 13 device types. The FDA files 19 510(k) clearances under its listings, the newest dated November 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012649202
- Address
- 2 Rue Jacqueline Auriol, Le Plessis-Pate Essonne, France, 91220
- Owner or operator
- Coloplast Corp. (8010144)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- February 27, 1995
- Registered through
- 2026
- Brand names listed
- Biosoft Duo Double Loop Stent Kit, BoNee Needle, Chiba needle, Dormia DualPerc, Dormia No Tip, Dornia N-Stone, EasiVac, Elefant Suction-Irrigation Device and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 2024 | K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | FED | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| June 8, 2022 | K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | FAD | Unknown | Coloplast Corp. | accessdata.fda.gov |
| March 10, 2022 | K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | LJE | Unknown | Coloplast Corp. | accessdata.fda.gov |
| February 16, 2022 | K213186 | NovoFlow Reinforced Ureteral Stent | FAD | Unknown | Coloplast Corp. | accessdata.fda.gov |
| February 25, 2021 | K201436 | Vortek Single Loop Ureteral Stent | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 6, 2018 | K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| October 4, 2018 | K182122 | Ureteric Catheters | EYB | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| September 7, 2018 | K181811 | ReTrace Ureteral Access Sheath | FED | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| March 9, 2018 | K180057 | VORTEK URETERAL DOUBLE LOOP STENT | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| December 21, 2017 | K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | EYB | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 15, 2017 | K170362 | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 2, 2017 | K170422 | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| August 17, 2017 | K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | EZN | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| August 17, 2016 | K160766 | Ambu USR, Ambu M | FAJ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| May 27, 2015 | K150927 | 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 | OCY | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| July 24, 2014 | K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | FED | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| April 23, 2009 | K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 | FBK | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| January 4, 2002 | K013174 | PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, | EZL | Substantially Equivalent | Porges S.A. | accessdata.fda.gov |
| December 20, 2001 | K013172 | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL | EZL | Substantially Equivalent | Porges S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
- All makers of Stent, Ureteral
- All makers of Endoscopic Guidewire, Gastroenterology-Urology
- All makers of Evacuator, Bladder, Manually Operated
- All makers of Catheter, Retention Type, Balloon
- All makers of Catheter, Nephrostomy
Updated November 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.