Identity
- Trade Name
- AEM® Monitor FDA UDI
- Generic Name
- Electrosurgical system monitor/shield FDA UDI
- Model / Reference
- EM3+ FDA UDI
Identifiers
- Catalog Number
- EM3+ FDA UDI
- Primary DI / UDI-DI
- 10815288014147 FDA UDI
- 510(k) Number
- K122383 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system monitor/shield 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system monitor/shield
AEM® Monitor by Encision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system monitor/shield.
- Orpheus CAST 15 inch — ORPHEUS MEDICAL LTD · Class II
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- AEM® Monitor, Loaner — ENCISION, INC. · Class II
- AEM® Monitor -ZE — ENCISION, INC. · Class II
- Disposable Sheath — ENCISION, INC. · Class II
- AEM EndoShield® Burn Protection System — ENCISION, INC. · Class II
- Disposable Sheath — ENCISION, INC. · Class II
Cleared under the same submission
K122383 also covers:
- AEM® Monitor — ENCISION, INC.
- AEM® Monitor -ZE — ENCISION, INC.
- EM3 Bipolar Adapter, Standard — ENCISION, INC.
- EM3 Bipolar Adapter, Standard — ENCISION, INC.
- EM3 Monopolar Adapter, Universal — ENCISION, INC.
- EM3 Monopolar Adapter, Universal — ENCISION, INC.
- EM3 Monopolar Adapter, Universal — ENCISION, 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
- Encision, Inc.
Sources (1)
- FDA UDI b1e45245-aade-4d42-b1c2-d2e209dfe7d4 34 fields · synced May 31, 2026