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510(k) K032688

COLONOSIGHT MODEL 510B by Sightline Technologies , Ltd. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2004
Date Received
August 29, 2003
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 Sightline Technologies , Ltd.

  • K011825 — RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE (July 11, 2001)
  • K994130 — RECTOSIGHT RS 300-04 (June 30, 2000)

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