Identity
- Trade Name
- FC-81 FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Model / Reference
- FC-81 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589551389414 FDA UDI
- 510(k) Number
- K233117 FDA UDI
- FDA Product Code
- EBW FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Fc-81 by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233117 also covers:
- Cleaning Wire — NAKANISHI INC.
- Coolant Solution Hanger Post — NAKANISHI INC.
- Handpiece Stand — NAKANISHI INC.
- Nozzle Holder — NAKANISHI INC.
- SG80M — NAKANISHI INC.
- SGL80M — NAKANISHI INC.
- Surgic Pro2 NON-OPT — NAKANISHI INC.
- Surgic Pro2 OPT — NAKANISHI INC.
- Tube Holder — NAKANISHI INC.
- Tube Holder — NAKANISHI INC.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI 878f9a46-5d7a-46ed-8c98-2247220dde39 33 fields · synced May 30, 2026