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510(k) K242325

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models by Actuated Medical, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2024
Date Received
August 6, 2024
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 Actuated Medical, Inc.

  • K251041 — GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (October 31, 2025)
  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
  • K220890 — IO Needle Safety Sheath (October 31, 2022)
  • K200646 — TubeClear System (December 4, 2020)
  • K172556 — TubeClear System (June 29, 2018)
  • K163092 — TubeClear Control Box and Clearing Stem (November 30, 2016)
  • K131052 — TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) (August 16, 2013)
  • K123659 — TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TU (December 20, 2012)
  • K121571 — TUBECLEAR (June 13, 2012)

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)
  • 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)
  • K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (September 8, 2023)