EndoClot
FDA 510(k) K191254 · Endoclot Plus Co., Ltd.
510(k) numberK191254
Submission
- Device name
- EndoClot
- Applicant
- Endoclot Plus Co., Ltd.
Suzhou, CN - Received
- May 10, 2019
- Decision date
- January 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)PLL · Traditional | Ovesco Endoscopy AG | 08/11/2022SE |
| 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 |
| K180068 | ORISE GelPLL · Traditional | Boston Scientific | 09/28/2018SE |
| K150852 | Sic 8000PLL · Traditional | Cosmo Technologies, Ltd. | 09/03/2015SE |
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Questions and answers
When was EndoClot cleared by the FDA?
EndoClot (K191254) received a 510(k) decision of Substantially Equivalent on January 30, 2020, 265 days after the submission was received.
What is the product code of K191254?
The FDA product code is PLL – Submucosal Injection Agent, a Class II (moderate risk) device regulated under 21 CFR 876.1500.