FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Delta III Pro
K Number: K221903
·
Decision Feb 22, 2023
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
40
Review Days
237
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Basic Information
- Device Name
- Delta III Pro
- K Number
- K221903
- 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
- June 30, 2022
- Decision Date
- February 22, 2023
- 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
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Break Wave
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FDA Class 2
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Extracorporeal Shock Wave Lithotripter (U200)
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FDA Class 2
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LM-9300 Plus Lithotripter
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FDA Class 2
·Gastroenterology, Urology
Modulith SLX-F2
FDA 510(k)
FDA Class 2
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Delta III Lithotripter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Dornier Medtech America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |