Aerin Medical Wand Model FG011
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150637 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aerin Medical Wand Model FG011 is a medical device indicated for use in otorhinolaryngology (ENT) surgery. It is designed for the coagulation of soft tissue in the nasal airway to treat nasal airway conditions.
This device has received FDA 510(k) clearance. It is manufactured by Aerin Medical, Inc. and is identified by the reference number K150637.
Frequently asked questions
What is the primary clinical use of the Aerin Medical Wand Model FG011?
This device is indicated for use in otorhinolaryngology (ENT) surgery. Specifically, it is designed to perform the coagulation of soft tissue located in the nasal airway to assist in the treatment of nasal airway conditions.
What is the regulatory status of the Aerin Medical Wand Model FG011?
The Aerin Medical Wand Model FG011 has received FDA 510(k) clearance. It is identified in the regulatory database under the reference number K150637, which confirms its status as substantially equivalent to existing devices.
Who is the manufacturer of the Aerin Medical Wand Model FG011?
The device is manufactured by Aerin Medical, Inc., which is based in Sunnyvale, California. The company is the official applicant for the device's regulatory clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Aerin Medical Incorporated Scott Wolf, M.D., Aerin Medical Wand Model FG011 (K150637) — FDA 510(k) | Innolitics, Aerin Medical Wand Model FG011 510(k) K150637 - FDA.report, Aerin Medical, Inc. FDA 510 (k) Products - Latest 2026, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150637 | Class II | Active |
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Manufacturer
- Manufacturer
- Aerin Medical Inc.
- FDA Applicant
- Aerin Medical, Inc.
Sources (1)
- FDA 510(k) K150637 24 fields · synced Sep 24, 2026