Identity
- Trade Name
- hoboat FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Model / Reference
- ZKN-2J FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955045516440 FDA UDI
- 510(k) Number
- K232703 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
hoboat by Jiangsu Hope Biomedical Science & Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.
- nxt™ Bipolar Forceps — adeor Medical AG · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
Cleared under the same submission
K232703 also covers:
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- hoboat — Jiangsu Hope Biomedical Science & Technology 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 |
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Manufacturer
Sources (1)
- FDA UDI 9afc8ecc-d241-4c7a-90f6-a0ad6273c12e 33 fields · synced Jun 1, 2026