LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
FDA 510(k) K221385 · Ovesco Endoscopy AG
510(k) numberK221385
Submission
- Device name
- LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
- Applicant
- Ovesco Endoscopy AG
Tuebingen, DE - Received
- May 13, 2022
- Decision date
- August 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PLL – Submucosal Injection Agent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code PLL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260997 | Sis Blu (SISBLU-30-01);SIS Blu (SISBLU-15-01)PLL · Traditional | Endoclot Plus Co., Ltd. | 09/09/2026SE |
| K241591 | Blue EyePLL · Special | The Standard Co., Ltd. | 07/03/2024SE |
| K220434 | Blue Eye (TS-905)PLL · Traditional | The Standard Co., Ltd. | 08/12/2022SE |
| K200071 | Blue Beacon Submucosal Injectable SolutionPLL · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 11/03/2020SE |
| K202376 | EverLift Submucosal Lifting AgentPLL · Special | Gi Supply, Inc. | 09/30/2020SE |
| K191923 | EverLift Submucosal Lifting AgentPLL · Traditional | Gi Supply | 06/20/2020SE |
| K191254 | EndoClotPLL · Traditional | Endoclot Plus Co., Ltd. | 01/30/2020SE |
| K180068 | ORISE GelPLL · Traditional | Boston Scientific | 09/28/2018SE |
| K150852 | Sic 8000PLL · Traditional | Cosmo Technologies, Ltd. | 09/03/2015SE |
More from Cosmo Technologies, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n)PKL · Traditional | 12/18/2025SE |
| K242586 | ArgoCap (200.52)OCX · Traditional | 05/22/2025SE |
| K241858 | BARS Set (100.60)PKL · Traditional | 08/26/2024SE |
| K200684 | gastroduodenal FTRD SetPKL · Traditional | 06/02/2020SE |
| K183309 | stentfix OTSC System SetPKL · Traditional | 10/22/2019SE |
| K170867 | FTRD System SetPKL · Traditional | 07/25/2017SE |
| K153550 | FTRD System SetPKL · Traditional | 10/12/2016SE |
| K150067 | OTSC ProctologyPKL · Traditional | 09/16/2015SE |
| K141790 | AqanifeGEI · Traditional | 03/06/2015SE |
| K141794 | Endo-Maryland DissectorKGE · Traditional | 11/19/2014SE |
Questions and answers
When was LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) cleared by the FDA?
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (K221385) received a 510(k) decision of Substantially Equivalent on August 11, 2022, 90 days after the submission was received.
What is the product code of K221385?
The FDA product code is PLL – Submucosal Injection Agent, a Class II (moderate risk) device regulated under 21 CFR 876.1500.