FDA Registration
Active
🇺🇸 United States
KAPP SURGICAL INSTRUMENT, INC.
Reg #: 1522875
·
FEI: 1522875
·
Expires 2026
Products
23
Proprietary Names
46
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- KAPP SURGICAL INSTRUMENT, INC.
- Registration Number
- 1522875
- FEI Number
- 1522875
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4919 WARRENSVILLE CENTER RD.
- City
- Bedford Heights
- State
- OH
- ZIP
- 44128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K033930
Owner / Operator
- Firm Name
- KAPP SURGICAL INSTRUMENT, INC.
- Operator Number
- 1522875
- Address
- 4919 WARRENSVILLE CENTER RD., --
- City
- WARRENSVILLE HEIGHTS
- State
- OH
- Postal Code
- 44128
- Country
- US
- Correspondent
- ALBERT N SANTILLI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2006-01-31 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2021-04-19 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-31 |
| Clamp, Carotid Artery | HCE | Class 2 | Neurology | No | 2020-11-17 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2002-09-04 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2006-01-31 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-12-01 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1989-02-13 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2020-11-17 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1989-02-13 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-31 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2023-12-01 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2023-12-01 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2002-09-04 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2023-12-01 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2002-09-04 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-31 |
Proprietary Names
KAPP CUSTOM ULNAR
Michler-Kapp Cardiovascular Vent Cathter
MTF Impactor
Hip Impactor
Liberty Mallots
Staple Impactor
Modified Javid Clamps
Chisel
KAPP CVT SUCTION STABILIZER
Coned Heparin Needles
KAPP CUSTOM RADIAL
MTF Trial
IMOBILIZER
IKI
KAPP KNEE BRACE
KISS
INTRA-OPERATIVE KNEE
Baby Renal
Humphries Aorta Aneurysm Clamp
Loop Aorta Clamp
Bulldog
Beven Aorta Aneurysm Clamp
Adult Renal
Martinez Clamp
Coolen Sternum Retractor
McCarthy Retractor
Cosgrove Mitral Valve Retractor
Ankeney Sternal Retractor
IMA Mammary Retractor
Knee Retractor
Reosenkranz Retractor
Gillanov Hand Held Maze Retractor
Bariatric
Ptosis Clamp
Vasectomy
S&L Awl
Seitz Swl
MTF Tamp
MTF Inserter
STRIP-T'S
Endardectomy blade
Endardectomy Handle
MTF Rasp
KAPP RECTAL DILATOR
Resano Forceps
9-17mm Reamer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device