FDA Registration
Active
🇺🇸 United States
ENDOPLUS
Reg #: 1423714
·
FEI: 3000719482
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ENDOPLUS
- Registration Number
- 1423714
- FEI Number
- 3000719482
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 750 Tower Rd Ste A
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K925114
Owner / Operator
- Firm Name
- ENDOPLUS
- Operator Number
- 9005786
- Address
- 750 Tower Road, SUITE A
- City
- Mundelein
- State
- IL
- Postal Code
- 60060
- Country
- US
- Correspondent
- Matthew S Gudeman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2013-01-30 |
| Coagulator, Culdoscopic (And Accessories) | HFI | Class 2 | Obstetrics/Gynecology | No | 2007-11-21 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-11-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-02-24 |
Proprietary Names
Ruggles
Reusable laparoscopic devices, inserts, handle and tube assemblies, coagulators, scissors, forceps
Endoplus Hand-held Laparoscopic Instruments
Reusable laparoscopic devices, inserts, handle and tube assy, scissors, forceps, knot pushers, probes, luer caps & ports
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device