Dornier MINNOW Ureteral Catheter
FDA 510(k) K191187 · Dornier Medtech America, Inc.
510(k) numberK191187
Submission
- Device name
- Dornier MINNOW Ureteral Catheter
- Applicant
- Dornier Medtech America, Inc.
Kennesaw, GA, US - Received
- May 3, 2019
- Decision date
- September 18, 2019
- 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
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|---|---|---|---|
| K192183 | RocaTub Ureteral CatheterEYB · Traditional | Promepal Sam | 04/23/2020SE |
| 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 |
| K182122 | Ureteric CathetersEYB · Traditional | Coloplast Corp. | 10/04/2018SE |
| 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 |
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| K220871 | NautilusJAA · Special | 04/18/2022SE |
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| K201815 | Dornier MAGELLAN Ureteral Access SheathFED · Traditional | 11/20/2020SE |
| K201074 | Delta III LithotripterLNS · Traditional | 09/03/2020SE |
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Questions and answers
When was Dornier MINNOW Ureteral Catheter cleared by the FDA?
Dornier MINNOW Ureteral Catheter (K191187) received a 510(k) decision of Substantially Equivalent on September 18, 2019, 138 days after the submission was received.
What is the product code of K191187?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.