FDA Registration
Active
🇺🇸 United States
72290037 Werewolf FLOW 50 Coblation Wand (E-beam)
Reg #: 3006524618
·
FEI: 3010813691
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ArthroCare Corporation
- Registration Number
- 3006524618
- FEI Number
- 3010813691
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7000 W William Cannon Dr
- City
- Austin
- State
- TX
- ZIP
- 78735
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162074
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-10-07 |
Proprietary Names
72290037 Werewolf FLOW 50 Coblation Wand (E-beam)
72290068 Werewolf Power Cord/Manual - Japan
72290064 Werewolf Power Cord/Manual - Korea
72290062 Werewolf Power Cord/Manual - Scandinavia
72290060 Werewolf Power Cord/Manual - EU Spanish
72290057 Werewolf Power Cord/Manual - US English
72290065 Werewolf Power Cord/Manual - Switzerlalnd
72290067 Werewolf Power Cord/Manual -Australia
Werewolf Cobation System (RF20000) with FLOW IQ Technology
72290008 Wireless Foot Contol
72290063 Werewolf Power Cord/Manual - Russia
72290059 Werewolf Power Cord/Manual - W. Europe
72290061 Werewolf Power Cord/Manual - EU English
72290058 Werewolf Power Cord/Manual - N. America
72290066 Werewolf Power Cord/Manual - China
72290105 Werewolf RF20000 Controller
72290007 Wired Foot Control
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CoVator 20
Ambient MegaVac 90
Super TurboVac 90
StarVac 90
Sidewinder Blade
TOPAZ EZ MicroDebrider IFS
Ambient CoVac 70 IFS
KVac
Ambient CoVac 50 IFS
TOPAZ XL IFS
Ambient Kvac IFS
Ambient HipVac 50 IFS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility