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510(k) K100966

COLONOSCOPE/SIGMOIDOSCOPE SHEATHES by Sheathing Technologies, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2010
Date Received
April 8, 2010
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 Sheathing Technologies, Inc.

  • K153212 — Sheathes Ultrasound Probe Covers (March 4, 2016)
  • K130041 — SHEATHES STERILE ULTRASOUND GEL (February 6, 2013)
  • K112827 — SHEATHES ULTRASOND GEL (June 22, 2012)
  • K091828 — SHEATHESISO ULTRASOUND TRANSDUCER COVER (September 28, 2009)
  • K043425 — SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBER (February 28, 2005)
  • K990175 — SHEATHES (NON-LATEX), STERILE (April 21, 1999)

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  • 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)