FDA Registration
Active
🇺🇸 United States
KIRWAN SURGICAL PRODUCTS, LLC.
Reg #: 1219619
·
FEI: 1219619
·
Expires 2026
Products
14
Proprietary Names
38
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- KIRWAN SURGICAL PRODUCTS, LLC.
- Registration Number
- 1219619
- FEI Number
- 1219619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 180 Enterprise Dr
- City
- MARSHFIELD
- State
- MA
- ZIP
- 02050
- Country
- US
Regulatory Submissions
- 510(k) Number
- K844823
Owner / Operator
- Firm Name
- KIRWAN SURGICAL PRODUCTS LLC
- Operator Number
- 1219619
- Address
- 180 ENTERPRISE DR., P.O. BOX 427
- City
- Marshfield
- State
- MA
- Postal Code
- 02050
- Country
- US
- Correspondent
- Matthew R Prario
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | Class 2 | Obstetrics/Gynecology | No | 2007-12-06 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-12-06 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 1992-12-31 |
| Apparatus, Electrosurgical | HAM | Class 2 | General, Plastic Surgery | No | 2007-12-06 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 1992-12-31 |
| Clamp, Carotid Artery | HCE | Class 2 | Neurology | No | 2007-12-06 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 1992-12-31 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2007-12-06 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1992-12-31 |
| Unit, Cautery, Thermal, Battery-Powered | HQP | Class 2 | Ophthalmic | No | 2007-03-20 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2010-12-06 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2007-12-06 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2007-12-06 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2007-12-06 |
Proprietary Names
Microinfertility Forceps, Titanium
Bipolar Suction Coagulator
Chisel
Osteotome
Aura 20 Watt Bipolar Electrosurgical Coagulator, Model 26-2500
Disposable Irrigation Bipolar Cord Assembly
Bipolar Reusable Forceps
Disposable Endoscopic Cord
Disposable Monopolar Cord
Reusable Endoscopic Cord
Reusable Monopolar Cord
Monopolar Suction Coagulator
Bipolar Reusable Cord
Bipolar Disposable Cord
Mallet
Carotid Artery Clamp
;REAMING FORCESP
ETRACT
ORTHOPEDIC/NALEBUFF
GLENOID PUNCHES
AURA 70 WATT BIPOLAR ELE
Wire Pass Drills
Cranio Blades
Bipolar Intraocular Probe
Bipolar Pencil
Handswitching Momopolar Pencil
Monopolar Pencil
Microsurgical Instrument
Kirwan Disposable Battery-powered Cautery, Model 41-61XX series
Disposable Bipolar Coagulating Forceps
Monopolar Chuck Handle
Kirwan Disposable Nerve Stimulating Probes, 41-34XX Series
Reusable Bipolar Pencil Coagulator
Disposable Bipolar Pencil Coagulator
Kirwan Monopolar Forceps
Irrigation/Aspiration Handpiece
Microdissection Needles
Needle Electrode
Establishment Types
Manufacture Medical Device