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510(k) K100966

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

K100966 is an FDA 510(k) premarket notification submitted by Sheathing Technologies, Inc. for the device "COLONOSCOPE/SIGMOIDOSCOPE SHEATHES". The FDA issued a decision of Substantially Equivalent on August 3, 2010. The device falls under product code FDF (Colonoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Sheathing Technologies, Inc. has at least 6 other 510(k) clearances on record.

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)

Other clearances for product code FDF

  • K260503 — Triton 1 System (September 3, 2026)
  • K261015 — Solo Scope Colonoscope System (August 21, 2026)
  • K261587 — Insufflation Retention Device (IRD) (11173-325-101) (July 2, 2026)
  • K260423 — Disposable Endoscopic Distal Attachments (May 28, 2026)
  • 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)

FDA data resources