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510(k) K163492

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear by United States Endoscopy Group, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2017
Date Received
December 13, 2016
Clearance Type
Special
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 United States Endoscopy Group, Inc.

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  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K192059 — Bio Guard Air/Water & Suction Valves (September 17, 2019)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182909 — Roth Net Retriever Product Line (November 21, 2018)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K172805 — gi-4000 Electrosurgical Generator (October 23, 2017)
  • K163495 — AdvanCE capsule endoscope delivery device (March 10, 2017)
  • K153362 — AquaShield system CO2, AquaShield system-PENTAX (December 16, 2015)

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)