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510(k) K153483

Balloon controller PB-30 by Fujifilm Medical Systems U.S.A, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2015
Date Received
December 3, 2015
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 Fujifilm Medical Systems U.S.A, Inc.

  • K171291 — FUJIFILM Bronchoscope Model EB-530P (January 19, 2018)
  • K171207 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (January 11, 2018)
  • K173132 — ASPIRE Cristalle (October 27, 2017)
  • K171463 — ASPIRE Bellus II (September 29, 2017)
  • K152257 — Fujifilm Duodenoscope Model ED-530XT (July 21, 2017)
  • K163624 — Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL (June 30, 2017)
  • K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (June 15, 2017)
  • K171096 — Fujifilm Diathermic Slitter (FlushKnife) (May 9, 2017)
  • K170858 — FDR AQRO (DR-XD 1000) (April 24, 2017)
  • K162287 — Synapse 3D Perfusion Analysis (April 6, 2017)

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)