FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dornier MINNOW Ureteral Catheter
K Number: K191187
·
Decision Sep 18, 2019
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
27
Applicant Total
40
Review Days
138
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
- Dornier MINNOW Ureteral Catheter
- K Number
- K191187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dornier Medtech America, Inc.
- Date Received
- May 3, 2019
- Decision Date
- September 18, 2019
- 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
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
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Dornier Medtech America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221903 | Delta III Pro | Feb 22, 2023 | Substantially Equivalent |
| K213252 | Dornier Thulio | Jul 27, 2022 | Substantially Equivalent |
| K220871 | Nautilus | Apr 18, 2022 | Substantially Equivalent |
| K210394 | Electrosurgical accessory | May 19, 2021 | Substantially Equivalent |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Nov 20, 2020 | Substantially Equivalent |
| K201074 | Delta III Lithotripter | Sep 3, 2020 | Substantially Equivalent |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dec 6, 2019 | Substantially Equivalent |
| K190312 | Dornier Ureteral Stent | Nov 15, 2019 | Substantially Equivalent |
| K172084 | Delta III Lithotripter | Aug 8, 2017 | Substantially Equivalent |
| K161771 | Medilas H Laser Fibers | Jul 28, 2016 | Substantially Equivalent |