Identity
- Trade Name
- Vaporflex® FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- Vaporflex® Handle and Shaft 320 FDA UDI
- Model / Reference
- JVH32030 FDA UDI
- Description
- Vaporflex® Handle and Shaft 320 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337103875 FDA UDI
- 510(k) Number
- K161378 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency ablation system 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
Moist Heat or Steam Sterilization FDA UDI
Category: Radio-frequency ablation system
Vaporflex® by Joimax, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- CP-16 TIP — Jeisys Medical Inc. · Class IIb
- 10THERMA Electrode — TENTECH Inc. · Class IIb
- Acessa ProVu PFG Table Clamp — ACESSA HEALTH INC. · Class II
- DIAMOND TIP — Jeisys Medical Inc. · Class IIb
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
Cleared under the same submission
K161378 also covers:
- Endovapor® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Vaporace® Hand Piece, bipolar — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 150 mm – 3.5 mm — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 270 mm – 3.5 mm — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 320 mm – 3.5 mm — JOIMAX, INC.
- Vaporace®/Vaporgrip® Kabel, L 3, 0 m — JOIMAX, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (1)
- FDA UDI d7ae3eae-32c9-4348-a71f-a5b87d137a6d 35 fields · synced May 31, 2026