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510(k) K113062

ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES by Endoservice Optical Instruments GmbH — Product Code FBP

K113062 is an FDA 510(k) premarket notification submitted by Endoservice Optical Instruments GmbH for the device "ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES". The FDA issued a decision of Substantially Equivalent on August 21, 2012. The device falls under product code FBP (Telescope, Rigid, Endoscopic), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2012
Date Received
October 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Telescope, Rigid, Endoscopic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances for product code FBP

  • K151191 — OES ELITE Telescopes, Protective Tube (November 24, 2015)
  • K031758 — ACMI M4 TELESCOPES (September 2, 2003)
  • K984607 — PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WIT (March 5, 1999)
  • K760177 — TELESCOPE, RIGID ENDOSCOPE (August 30, 1976)

FDA data resources