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510(k) K083840

MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE by Msi Medserv International Deutschland GmbH — Product Code GCM

K083840 is an FDA 510(k) premarket notification submitted by Msi Medserv International Deutschland GmbH for the device "MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on September 28, 2009. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2009
Date Received
December 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code GCM

  • K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM (May 14, 2021)
  • K001217 — INSIDE VIEW (July 11, 2000)
  • K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOS (December 10, 1999)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (September 17, 1996)
  • K950712 — PORTABLE ENDOSCOPY SYSTEM (May 14, 1996)
  • K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR (January 26, 1996)
  • K935235 — ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY (March 23, 1995)
  • K945889 — KARL STORZ PLASTIC SURGERY ACCESSORIES (March 22, 1995)
  • K931954 — THORACOSCOPE/LAPAROSCOPE (November 2, 1993)

FDA data resources