DiLumen Endolumenal Interventional Platform
FDA 510(k) K182540 · Lumendi, LLC
510(k) numberK182540
Submission
- Device name
- DiLumen Endolumenal Interventional Platform
- Applicant
- Lumendi, LLC
Westport, CT, US - Received
- September 14, 2018
- Decision date
- October 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221452 | DiLumen C1, EZ1 and Tool MountFDF · Traditional | 02/10/2023SE |
| K211819 | DiLumen C2 and Tool MountFDF · Traditional | 10/22/2021SE |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen)FDF · Special | 04/21/2021SE |
| K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK)GEI · Traditional | 08/02/2019SE |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is)GEI · Traditional | 05/22/2018SE |
| K173317 | DiLumen C2; DiLumen Tool MountFDF · Traditional | 04/17/2018SE |
| K162428 | DiLumen Endolumenal Interventional PlatformFDF · Traditional | 12/06/2016SE |
Questions and answers
When was DiLumen Endolumenal Interventional Platform cleared by the FDA?
DiLumen Endolumenal Interventional Platform (K182540) received a 510(k) decision of Substantially Equivalent on October 30, 2018, 46 days after the submission was received.
What is the product code of K182540?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.