Identity
- Trade Name
- Sense Medical FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Bipolar Pencil 18 Gauge Straight FDA UDI
- Model / Reference
- 14500 FDA UDI
- Description
- Bipolar Pencil 18 Gauge Straight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019110089 FDA UDI
- 510(k) Number
- K864402 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Sense Medical by Sense Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
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Cleared under the same submission
K864402 also covers:
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- Alpin — Alpin Surgical Specialties Inc
- Alpin — Alpin Surgical Specialties Inc
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Sense Medical Llc
Sources (1)
- FDA UDI 80c0068c-0b71-47ce-8a54-7f0fd677e5d3 35 fields · synced Jun 6, 2026