FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DiLumen Endolumenal Interventional Scissors (DiLumen Is)
K Number: K173405
·
Decision May 22, 2018
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
8
Review Days
203
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Basic Information
- Device Name
- DiLumen Endolumenal Interventional Scissors (DiLumen Is)
- K Number
- K173405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumendi, LLC
- Date Received
- October 31, 2017
- Decision Date
- May 22, 2018
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Lumendi, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K221452 | DiLumen C1, EZ1 and Tool Mount | Feb 10, 2023 | Substantially Equivalent |
| K211819 | DiLumen C2 and Tool Mount | Oct 22, 2021 | Substantially Equivalent |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Apr 21, 2021 | Substantially Equivalent |
| K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK) | Aug 2, 2019 | Substantially Equivalent |
| K182540 | DiLumen Endolumenal Interventional Platform | Oct 30, 2018 | Substantially Equivalent |
| K173317 | DiLumen C2; DiLumen Tool Mount | Apr 17, 2018 | Substantially Equivalent |
| K162428 | DiLumen Endolumenal Interventional Platform | Dec 6, 2016 | Substantially Equivalent |