K221385 is an FDA 510(k) clearance for the LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02). This device is classified as a Submucosal Injection Agent (Class II - Special Controls, product code PLL).
Submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Cleared decision on August 11, 2022, 90 days after receiving the submission on May 13, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Intended For Use In Gastrointestinal Endoscopic Procedures For Submucosal Lift Of Polyps, Adenomas, Early-stage Cancers Or Other Gastrointestinal Mucosal Lesions, Prior To Excision With A Snare Or Endoscopic Device..
| 510(k) Number | K221385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2022 |
| Decision Date | August 11, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | PLL - Submucosal Injection Agent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Intended For Use In Gastrointestinal Endoscopic Procedures For Submucosal Lift Of Polyps, Adenomas, Early-stage Cancers Or Other Gastrointestinal Mucosal Lesions, Prior To Excision With A Snare Or Endoscopic Device. |