FDA Registration
Active
🇺🇸 United States
ELLIQUENCE LLC
Reg #: 3007024186
·
FEI: 3007024186
·
Expires 2026
Products
20
Proprietary Names
2
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- ELLIQUENCE LLC
- Registration Number
- 3007024186
- FEI Number
- 3007024186
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2455 Grand Avenue
- City
- Baldwin
- State
- NY
- ZIP
- 11510
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100390
Owner / Operator
- Firm Name
- Elliquence LLC
- Operator Number
- 10024988
- Address
- 2455 Grand Avenue
- City
- Baldwin
- State
- NY
- Postal Code
- 11510
- Country
- US
- Correspondent
- Dandan Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-07-23 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-09-08 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-03-02 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2011-12-05 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2024-12-24 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2016-11-17 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2018-03-02 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2024-12-24 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-12-24 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2018-03-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-12-24 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-03-02 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2018-03-02 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-03-06 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2018-03-02 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-12-24 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2018-03-02 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-10-09 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2018-03-02 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2018-03-02 |
Proprietary Names
AxCess
Ace Tip Electrodes
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility