K212382 is an FDA 510(k) clearance for the Ambu? aScope? Gastro, Ambu? aBox?2, a Gastroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDS), submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on February 3, 2022, 185 days after receiving the submission on August 2, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K212382 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2021 |
| Decision Date | February 03, 2022 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDS — Gastroscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |