FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dornier Thulio
K Number: K213252
·
Decision Jul 27, 2022
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
40
Review Days
300
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Basic Information
- Device Name
- Dornier Thulio
- K Number
- K213252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dornier Medtech America, Inc.
- Date Received
- September 30, 2021
- Decision Date
- July 27, 2022
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Dornier Medtech America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221903 | Delta III Pro | Feb 22, 2023 | 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 |