Identifiers
- 510(k) Number
- K150400 FDA 510(k)
- FDA Product Code
- MIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3620 FDA 510(k)
- Regulation Number
- 874.3620 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Renu Gel is an ear, nose, and throat synthetic polymer material intended to be implanted as a space-occupying substance in the reconstructive surgery of the head and neck. It is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus.
Renu Gel is a Class 2 device with product code MIX, cleared via the FDA 510(k) pathway under regulation number 874.3620. The device was granted Special 510(k) clearance K150400 on April 6, 2015, following a 47-day review, and is manufactured by Cytophil, Inc. in East Troy, WI.
Frequently asked questions
What is Renu Gel used for?
Renu Gel is intended to be implanted as a space-occupying substance in reconstructive surgery of the head and neck, including applications such as augmentation rhinoplasty and closure of tissue defects in the esophagus.
How is Renu Gel supplied and is it sterile?
The device data does not specify the supply format or sterility status of Renu Gel; therefore, no details about its packaging, sterilization method, or single-use versus reusable nature can be provided based on the available information.
What regulatory pathway was used for Renu Gel?
Renu Gel received Special 510(k) clearance under K150400 on April 6, 2015, following a 47-day review, and is classified as a Class 2 device with product code MIX under regulation 874.3620.
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: Renu Gel (K150400) — FDA 510 (k) | Innolitics, Renu Gel by CYTOPHIL, INC. | FDA 510 (k) Summary, K150400 FDA 510 (k) - Renu Gel | Cytophil, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150400 | Class II | Active |
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Manufacturer
- Manufacturer
- Cytophil, Inc.
Sources (1)
- FDA 510(k) K150400 24 fields · synced Sep 24, 2026