Identity
- Trade Name
- Sense Medical FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Single Use Monopolar Suction Coagulator 10 French with 10ft. (3m) Monopolar Cord FDA UDI
- Model / Reference
- 10700 FDA UDI
- Description
- Single Use Monopolar Suction Coagulator 10 French with 10ft. (3m) Monopolar Cord FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019110072 FDA UDI
- 510(k) Number
- K895337 FDA UDI
- FDA Product Code
- HAM FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use 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
Dimensions & Sizes
- Size
- Length — 10 Feet FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Sense Medical by Sense Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
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- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr — KIRWAN SURGICAL PRODUCTS LLC · Class IIb
- Valleylab — Covidien LP · Class II
- A&E Medical / Disposable Suction Coagulator — A & E MEDICAL CORPORATION · Class II
- PlasmaBladeTM — MEDTRONIC NAVIGATION, INC. · Class II
Cleared under the same submission
K895337 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
- Sense Medical Llc
Sources (1)
- FDA UDI 57e457cd-4363-4984-a2f6-d936dd103e0c 36 fields · synced May 30, 2026