DiLumen Endolumenal Interventional Knife (DiLumen IK)
FDA 510(k) K183112 · Lumendi, LLC
510(k) numberK183112
Submission
- Device name
- DiLumen Endolumenal Interventional Knife (DiLumen IK)
- Applicant
- Lumendi, LLC
Westport, CT, US - Received
- November 8, 2018
- Decision date
- August 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K221452 | DiLumen C1, EZ1 and Tool MountFDF · Traditional | 02/10/2023SE |
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| K182540 | DiLumen Endolumenal Interventional PlatformFDF · Traditional | 10/30/2018SE |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is)GEI · Traditional | 05/22/2018SE |
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| K162428 | DiLumen Endolumenal Interventional PlatformFDF · Traditional | 12/06/2016SE |
Questions and answers
When was DiLumen Endolumenal Interventional Knife (DiLumen IK) cleared by the FDA?
DiLumen Endolumenal Interventional Knife (DiLumen IK) (K183112) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 267 days after the submission was received.
What is the product code of K183112?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.