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DiLumen Is Endolumenal Interventional Scissors
FDA UDIClass II (US FDA UDI)
by Lumendi Llc
Identity
- Trade Name
- DiLumen Is Endolumenal Interventional Scissors FDA UDI
- Generic Name
- Flexible endoscopic scissors, single-use FDA UDI
- Device Name
- The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically FDA UDI
- Model / Reference
- DiLumen Is 140 cm FDA UDI
- Description
- The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically FDA UDI
Identifiers
- Catalog Number
- D-3101 FDA UDI
- Primary DI / UDI-DI
- 00865309000263 FDA UDI
- 510(k) Number
- K173405 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Flexible endoscopic scissors, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible endoscopic scissors, single-use
DiLumen Is Endolumenal Interventional Scissors by Lumendi Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Flexible endoscopic scissors, single-use.
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- ReNew — MICROLINE SURGICAL, INC. · Class II
- ENSIZOR — Slater Endoscopy, LLC · Class II
- ReNew — MICROLINE SURGICAL, INC. · Class II
- Single Use Loop Cutter FS-410 — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K173405 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumendi Llc
Sources (1)
- FDA UDI 37c0aec4-89ae-469e-a0f6-f5f8de763396 36 fields · synced May 30, 2026