K231254 is an FDA 510(k) clearance for the GripTract-GI Endoscopic Tissue Manipulator, a Colonoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDF), submitted by Actuated Medical, Inc. (Bellefonte, US). The FDA issued a Cleared decision on November 3, 2023, 186 days after receiving the submission on May 1, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K231254 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 2023 |
| Decision Date | November 03, 2023 |
| Days to Decision | 186 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). |