Identity
- Trade Name
- Foot Switch FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- The foot switch is an accessory for use with the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. FDA UDI
- Model / Reference
- CAT307 FDA UDI
- Description
- The foot switch is an accessory for use with the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. FDA UDI
Identifiers
- Catalog Number
- CAT307 FDA UDI
- Primary DI / UDI-DI
- 08886479300139 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
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
No
FDA UDI
Category: Electrosurgical system
Foot Switch 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.
- InSeca ARC Stylus — 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 86abce9c-ce79-45e3-bce6-c1a5ffc4435f 36 fields · synced May 30, 2026