Data / Medical devices / United States / Coloplast Manufacturing US, LLC.
Coloplast Manufacturing US, LLC.: FDA-registered device maker in Brookshire, TX, United States, 3 510(k) clearances
Coloplast Manufacturing US, LLC. is registered with the FDA (registration 3030087693) in Brookshire, TX, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 2, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030087693
- Address
- 4008 Heritage Drive, Brookshire, TX, United States, 77423
- Owner or operator
- Coloplast Corp. (8010144)
- Roles
- Repackager or relabeler
- First device listed
- February 27, 1995
- Registered through
- 2027
- Brand names listed
- Assura 1pc Kit, Assura CV Kit, Assura Irrigation Pressplate, Assura Irrigation Set, Assura Kit, Assura Night bag, Assura Ostomy Pouch, Assura Urostomy Pouch and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Nephrostomy | LJE | U | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Collector, Ostomy | EXB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Ostomy | EXD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stent, Ureteral | FAD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 2, 2023 | K223821 | Self-Cath Closed System | FCM | Substantially Equivalent | Coloplast | 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 |
| July 16, 2012 | K121833 | OSTOMY IRRIGATION SET | EXD | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Nephrostomy, General & Plastic Surgery
- All makers of Garment, Protective, For Incontinence
- All makers of Dressing, Wound, Occlusive
- All makers of Catheter, Nephrostomy
- All makers of Stent, Ureteral
- All makers of Irrigator, Ostomy
Updated August 2, 2023. 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.