Identity
- Trade Name
- InSeca ARC Stylus FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable. FDA UDI
- Model / Reference
- FG256 FDA UDI
- Description
- The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable. FDA UDI
Identifiers
- Catalog Number
- CAT409 FDA UDI
- Primary DI / UDI-DI
- 08886479300023 FDA UDI
- 510(k) Number
- K162810 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system 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
Category: Electrosurgical system
InSeca ARC Stylus by Aerin Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162810 also covers:
- Aerin Console — Aerin Medical Inc.
- Aerin Console Set — Aerin Medical Inc.
- Foot Switch — Aerin Medical Inc.
- Power Cord — Aerin Medical Inc.
- Power Cord (OUS) — Aerin Medical Inc.
- Power Cord (OUS) 15 FT — Aerin Medical Inc.
- Power Cord (UK) — Aerin Medical Inc.
- Power Cord (UK) 15 FT — Aerin Medical Inc.
- Power Cord 15 ft (US) — Aerin Medical 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
- Aerin Medical Inc.
Sources (1)
- FDA UDI 7867281a-eef6-49b9-95bc-f35875b78855 37 fields · synced May 31, 2026