FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
K Number: K171043
·
Decision Dec 21, 2017
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
27
Applicant Total
54
Review Days
258
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
- K Number
- K171043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- April 7, 2017
- Decision Date
- December 21, 2017
- Product Code
- EYB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EYB), ordered by most recent decision date.
RocaTub Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dornier MINNOW Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UPJ Occlusion Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ureteric Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Coloplast Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K252140 | Heylo System | Oct 6, 2025 | Substantially Equivalent |
| K251116 | Luja Coudé | Jun 27, 2025 | Substantially Equivalent |
| K250270 | Luja Set | Apr 17, 2025 | Substantially Equivalent |
| K242049 | SureCath Set | Nov 26, 2024 | Substantially Equivalent |
| K241210 | Luja Coude | Nov 21, 2024 | Substantially Equivalent |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Nov 12, 2024 | Substantially Equivalent |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Oct 18, 2024 | Substantially Equivalent |
| K233411 | Folysil Silicone Catheter | Apr 15, 2024 | Substantially Equivalent |
| K231953 | 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 x 30 cm / 8 in x 12 in) | Mar 22, 2024 | Substantially Equivalent |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Oct 26, 2023 | Substantially Equivalent |