Identity
- Trade Name
- Hand Piece LIFT FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Model / Reference
- HP20-80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809495931361 FDA UDI
- 510(k) Number
- K222709 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Hand Piece LIFT by Chungwoo Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Electrode — SOPRO-COMEG GmbH · Class II
- Sklar® — Sklar Corporation · Class II
- PILLING — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K222709 also covers:
- APOLEX Tite — Chungwoo Co., Ltd.
- APOLEX Tite, Retraction — Chungwoo Co., Ltd.
- Electrode LIFT — Chungwoo Co., Ltd.
- Electrode LIPO — Chungwoo Co., Ltd.
- Electrode SMART — Chungwoo Co., Ltd.
- FOOT Switch — Chungwoo Co., Ltd.
- Hand Piece Electrode LIFT — Chungwoo Co., Ltd.
- Hand Piece Electrode LIPO — Chungwoo Co., Ltd.
- Hand Piece Electrode SMART — Chungwoo Co., Ltd.
- Hand Piece LIPO — Chungwoo Co., Ltd.
- Hand Piece SMART — Chungwoo Co., Ltd.
- Neutral Cable — Chungwoo Co., Ltd.
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
- Chungwoo Co., Ltd.
Sources (1)
- FDA UDI be5667fc-5945-413b-93c9-8dd4504f9579 34 fields · synced May 30, 2026