Home / 510(k) Clearances / K211819

510(k) K211819

DiLumen C2 and Tool Mount by Lumendi, LLC — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2021
Date Received
June 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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).

Other clearances by Lumendi, LLC

  • K221452 — DiLumen C1, EZ1 and Tool Mount (February 10, 2023)
  • K210851 — DiLumen Endolumenal Interventional Platform (DiLumen) (April 21, 2021)
  • K183112 — DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) (August 2, 2019)
  • K182540 — DiLumen Endolumenal Interventional Platform (October 30, 2018)
  • K173405 — DiLumen Endolumenal Interventional Scissors (DiLumen Is) (May 22, 2018)
  • K173317 — DiLumen C2; DiLumen Tool Mount (April 17, 2018)
  • K162428 — DiLumen Endolumenal Interventional Platform (December 6, 2016)

Other clearances for product code FDF

  • K252457 — Disposable Distal End Tape Hood (January 30, 2026)
  • K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (September 24, 2025)
  • K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM (May 23, 2025)
  • K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal (May 15, 2025)
  • K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) (January 3, 2025)
  • K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (October 4, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
  • K232922 — Pure-Vu EVS System (October 20, 2023)
  • K230332 — Ambu® aScope™ Colon; Ambu® aBox™ 2 (September 15, 2023)