Identity
- Trade Name
- Foot switch Single FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Enables and disables RF output in manual control mode FDA UDI
- Model / Reference
- FS01-02R FDA UDI
- Description
- Enables and disables RF output in manual control mode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306769046 FDA UDI
- 510(k) Number
- K163450 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
Foot switch Single by Starmed Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foot-switch, electrical.
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- Alligature-E — Alan Electronic Systems Private Limited · Class IIb
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · U
- Arthrex® — Arthrex, Inc. · Class I
- CableAME — Cambridge Interventional LLC · Class IIb
- CORE — Stryker Corp. · Class II
- PowerPack — MICROLINE SURGICAL, INC. · Class II
Cleared under the same submission
K163450 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Starmed Co., Ltd
Sources (1)
- FDA UDI a04fd0de-b5bd-45a3-b899-f18bedaff014 36 fields · synced May 30, 2026