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510(k) K011825

RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE by Sightline Technologies , Ltd. — Product Code FER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2001
Date Received
June 11, 2001
Clearance Type
Special
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)
  • K994130 — RECTOSIGHT RS 300-04 (June 30, 2000)

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  • K133687 — THD N-ANO ANOSCOPE (December 11, 2013)
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  • K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (June 1, 2012)
  • K110792 — GELPOINT PATH (May 23, 2011)