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510(k) K052084

ENDO-EASE ENDOSCOPIC OVERTUBE by Spirus Medical, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2005
Date Received
August 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances by Spirus Medical, Inc.

  • K080050 — SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE (May 6, 2008)
  • K080042 — SPIRUS MEDICAL SURGICAL INSTRUMENT (April 3, 2008)
  • K062805 — MODIFICATION TO ENDO-EASE (October 13, 2006)
  • K060235 — ENDO-EASE ENDOSCOPIC OVERTUBE (August 4, 2006)

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