Ureteric Catheters
FDA 510(k) K182122 · Coloplast Corp.
510(k) numberK182122
Submission
- Device name
- Ureteric Catheters
- Applicant
- Coloplast Corp.
Plymouth, MN, US - Received
- August 6, 2018
- Decision date
- October 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EYB – Catheter, Ureteral, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192183 | RocaTub Ureteral CatheterEYB · Traditional | Promepal Sam | 04/23/2020SE |
| K191187 | Dornier MINNOW Ureteral CatheterEYB · Traditional | Dornier Medtech America, Inc. | 09/18/2019SE |
| K183323 | UPJ Occlusion Balloon CatheterEYB · Traditional | Cook Incorporated | 08/05/2019SESK |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB · Traditional | Cook Incorporated | 06/17/2019SESK |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterEYB · Traditional | Cook Incorporated | 09/14/2018SE |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB · Traditional | Coloplast Corp. | 12/21/2017SE |
| K133750 | Occluder Occlusion Balloon CatheterEYB · Traditional | Boston Scientific Corporation | 01/08/2014SE |
| K092250 | Medline Red Rubber Urethral CatheterEYB · Traditional | Medline Industries, Inc. | 01/21/2010SE |
| K083788 | Endo Optiks Urological Catheter for Endoscopy, Model SessrEYB · Traditional | Endooptiks, Inc. | 03/03/2009SE |
| K043581 | Dual Lumen CatheterEYB · Special | Acmi Corporation | 03/03/2005SE |
More from Acmi Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | 10/06/2025SE |
| K251116 | Luja CoudéEZD · Traditional | 06/27/2025SE |
| K250270 | Luja SetEZD · Special | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
Questions and answers
When was Ureteric Catheters cleared by the FDA?
Ureteric Catheters (K182122) received a 510(k) decision of Substantially Equivalent on October 4, 2018, 59 days after the submission was received.
What is the product code of K182122?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.