FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Delta III Lithotripter
K Number: K201074
·
Decision Sep 3, 2020
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
40
Review Days
134
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
- Delta III Lithotripter
- K Number
- K201074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5990
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dornier Medtech America, Inc.
- Date Received
- April 22, 2020
- Decision Date
- September 3, 2020
- Product Code
- LNS
- 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNS), ordered by most recent decision date.
Break Wave
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Break Wave
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Extracorporeal Shock Wave Lithotripter (U200)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Delta III Pro
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LM-9300 Plus Lithotripter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Modulith SLX-F2
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 |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dec 6, 2019 | Substantially Equivalent |
| K190312 | Dornier Ureteral Stent | Nov 15, 2019 | Substantially Equivalent |
| K191187 | Dornier MINNOW Ureteral Catheter | Sep 18, 2019 | Substantially Equivalent |
| K172084 | Delta III Lithotripter | Aug 8, 2017 | Substantially Equivalent |
| K161771 | Medilas H Laser Fibers | Jul 28, 2016 | Substantially Equivalent |