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510(k) K921390

XENON LIGHT SOURCE AND ACCESSORIES by Coopervision Surgical — Product Code GCT

K921390 is an FDA 510(k) premarket notification submitted by Coopervision Surgical for the device "XENON LIGHT SOURCE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on Jul 27, 1992. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Coopervision Surgical has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 27, 1992
Date Received
Mar 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type
510(k) Exempt

Other clearances by Coopervision Surgical

  • K905747 — LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR (Sep 17, 1991)

Other clearances for product code GCT

  • K093125 — ALPHAXENON LIGHT 180 W AND 300 W (Jan 27, 2010)
  • K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (Dec 18, 2008)
  • K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE (Aug 20, 2007)
  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K022490 — KSEA MEDI PACK (Sep 29, 2003)
  • K031994 — LINVATEC 300W XENON LIGHT SOURCE (Aug 21, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (Jan 14, 2003)
  • K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (Aug 20, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (Jun 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (Dec 7, 2001)

FDA data resources

Source: FDA 510(k) database entry for K921390. Report a data issue: hello@regdatalab.com.