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510(k) K994130

RECTOSIGHT RS 300-04 by Sightline Technologies , Ltd. — Product Code FER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2000
Date Received
December 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anoscope And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures within the anus and rectum.

Other clearances by Sightline Technologies , Ltd.

  • K032688 — COLONOSIGHT MODEL 510B (March 5, 2004)
  • K011825 — RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE (July 11, 2001)

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  • K230439 — WellCare Anoscope (December 22, 2023)
  • K200021 — Applied Medical Anoscope (January 6, 2021)
  • K171701 — GelPOINT Path Transanal Access Platform (July 20, 2017)
  • K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORM (January 2, 2014)
  • K133687 — THD N-ANO ANOSCOPE (December 11, 2013)
  • K121604 — ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (July 27, 2012)
  • K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (June 1, 2012)
  • K110792 — GELPOINT PATH (May 23, 2011)