FDA Registration
Active
🇺🇸 United States
KLEIN SURGICAL SYSTEMS, INC.
Reg #: 1648701
·
FEI: 3000204261
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- KLEIN SURGICAL SYSTEMS, INC.
- Registration Number
- 1648701
- FEI Number
- 3000204261
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 400 N Loop 1604 E Ste 106
- City
- San Antonio
- State
- TX
- ZIP
- 78232
- Country
- US
Regulatory Submissions
- 510(k) Number
- K930496
Owner / Operator
- Firm Name
- KLEIN SURGICAL SYSTEMS, INC.
- Operator Number
- 9026062
- Address
- 400 N Loop 1604 E,, Suite 106
- City
- San Antonio
- State
- TX
- Postal Code
- 78232
- Country
- US
- Correspondent
- RICHARD H KLEIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2023-07-10 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2023-07-10 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2023-07-10 |
| Laryngoscope, Endoscope | GCI | Class 2 | Gastroenterology, Urology | No | 2011-03-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-07-10 |
Proprietary Names
Satinsky Laproscopic Clamp
TC Needle Holder
Klein Bulldog Clamp Applier
Klein Bulldogs
Solos Applier
GI-1088 AKA 300-400-775
Klein Applier
GI-1085 AKA 300-100-771, GI-1086 AKA 300-100-772,
GI-1085 AKA GI-1085U, GI-1095 AKA GI-1095U
GI-1090, 1095, 1080, 1085, 1086, 1088, ENDOSCOPIC CLAMPS
GI-1090 AKA 300-100-773, GI-1095 AKA 300-100-774,
Solos Bulldogs
Klein Sterilization Tray
Establishment Types
Repack or Relabel Medical Device