K242668 is an FDA 510(k) clearance for the Gastro Concepts Air Assist. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Gastro Concepts, LLC (Wilmington, US). The FDA issued a Cleared decision on December 13, 2024, 99 days after receiving the submission on September 5, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Anus And Rectum..
| 510(k) Number | K242668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2024 |
| Decision Date | December 13, 2024 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FER - Anoscope And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Anus And Rectum. |