Identity
- Trade Name
- Handlike FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Model / Reference
- HD-CSXT-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06957270301549 FDA UDI
- 510(k) Number
- K233036 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Soft-tissue ultrasonic surgical system
Handlike by Hunan Handlike Minimally Invasive Surgery Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue ultrasonic surgical system.
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 — AROBELLA MEDICAL, LLC · Class II
- Sonicision 7 — Covidien LP · U
- Sonicision — Covidien LP · U
- CUSA® Clarity — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 — AROBELLA MEDICAL, LLC · Class II
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 — AROBELLA MEDICAL, LLC · Class II
- CUSA® Excel — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
Cleared under the same submission
K233036 also covers:
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Handlike — Hunan Handlike Minimally Invasive Surgery 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.
Sources (1)
- FDA UDI 5b224685-3d1b-4650-9b51-d18d76606e3a 33 fields · synced May 30, 2026