Identity
- Trade Name
- LOBO FDA UDI
- Generic Name
- Non-neurovascular embolization plug, metallic FDA UDI
- Device Name
- LOBO Handpiece FDA UDI
- Model / Reference
- LOBO-HP FDA UDI
- Description
- LOBO Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008222009 FDA UDI
- 510(k) Number
- K192083 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Non-neurovascular embolization plug, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Category: Non-neurovascular embolization plug, metallic
Lobo by Okami Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-neurovascular embolization plug, metallic.
- Solus Gold™ Embolization Device — Artio Medical, Inc. · Class II
- HARBOR — Nuvascular, Inc. · Class II
- Micro Plug Set — Ka Medical, LLC · Class II
- Amplatzer™ — Aga Medical Corp. · Class II
- Solus Gold™ Embolization Device — Artio Medical, Inc. · Class II
- AMPLATZER™ — Aga Medical Corp. · Class II
- Amplatzer™ — Aga Medical Corp. · Class II
- Micro Plug Set — Ka Medical, LLC · Class II
Cleared under the same submission
K192083 also covers:
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
- Okami Medical Inc.
Sources (1)
- FDA UDI 42abc9de-ae38-4dcc-94cc-1a99a8b33c8d 35 fields · synced May 30, 2026