K213773 is an FDA 510(k) clearance for the Insufflation Retention Device. This device is classified as a Colonoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FDF).
Submitted by Bpendo, LLC (Norman, US). The FDA issued a Cleared decision on July 21, 2022, 231 days after receiving the submission on December 2, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine Or Perform Procedures In The Colon Or Rectum 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)..
| 510(k) Number | K213773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2021 |
| Decision Date | July 21, 2022 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDF - Colonoscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine Or Perform Procedures In The Colon Or Rectum 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). |