FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DORNIER LASER LITHOTRIPTER IMPACT
K Number: K913191
·
Decision Oct 16, 1991
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
40
Review Days
90
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 LASER LITHOTRIPTER IMPACT
- K Number
- K913191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dornier Medtech America, Inc.
- Date Received
- July 18, 1991
- Decision Date
- October 16, 1991
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K191187 | Dornier MINNOW Ureteral Catheter | Sep 18, 2019 | Substantially Equivalent |
| K172084 | Delta III Lithotripter | Aug 8, 2017 | Substantially Equivalent |