Identity
- Trade Name
- Permanent Adapter, SIE, Bard-Davol FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Model / Reference
- ES3710 FDA UDI
Identifiers
- Catalog Number
- ES3710 FDA UDI
- Primary DI / UDI-DI
- 10815288013089 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
- 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
Category: Surgical irrigation/aspiration handpiece, reusable
Permanent Adapter, SIE, Bard-Davol by Encision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration handpiece, reusable.
- Spetzler MacroVac® — Pmt Corp. · Class I
- SPETZLER MACROVAC® — Pmt Corp. · Class I
- Spetzler MacroVac® — Pmt Corp. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Accu-Beam — Transamerican Technologies International · Class II
- PMT® Suction Instruments — Pmt Corp. · Class I
- Spetzler MacroVac® — Pmt Corp. · Class I
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.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Encision, Inc.
Sources (1)
- FDA UDI c57aac9b-6d38-40d3-954e-993bcebf538a 34 fields · synced Jun 6, 2026