Identity
- Trade Name
- Adapter, SIE, Applied FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Model / Reference
- ES3810 FDA UDI
Identifiers
- Catalog Number
- ES3810 FDA UDI
- Primary DI / UDI-DI
- 10815288010941 FDA UDI
- 510(k) Number
- K100711 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Adapter, SIE, Applied by Encision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100711 also covers:
- AEM® Suction Irrigation Electrode J-Hook, 35cm — ENCISION, INC.
- AEM® Suction Irrigation Electrode L-Diamond, 35cm — ENCISION, INC.
- AEM® Suction Irrigation Electrode L-Hook, 35cm — ENCISION, INC.
- AEM® Suction Irrigation Electrode Spatula, 35cm — ENCISION, INC.
- Adapter, SIE, Applied — ENCISION, INC.
- Adapter, SIE, Bard-Davol — ENCISION, INC.
- Permanent Adapter, SIE, Bard-Davol — 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 a9bf9860-4345-4cf6-800d-83a17e1ae2a7 35 fields · synced Jun 7, 2026