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510(k) K921918

FIBER OPTIC ENDOSCOPE by Electro Fiberoptics Corp. — Product Code GCM

K921918 is an FDA 510(k) premarket notification submitted by Electro Fiberoptics Corp. for the device "FIBER OPTIC ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on August 17, 1993. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Electro Fiberoptics Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1993
Date Received
April 23, 1992
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 by Electro Fiberoptics Corp.

  • K943628 — ARTHROSCOPE (November 22, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)

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)
  • K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (September 28, 2009)
  • 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)

FDA data resources