Home / 510(k) Clearances / K031994

510(k) K031994

LINVATEC 300W XENON LIGHT SOURCE by Linvatec Corp. — Product Code GCT

K031994 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "LINVATEC 300W XENON LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on August 21, 2003. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. Linvatec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2003
Date Received
June 27, 2003
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

Other clearances by Linvatec Corp.

  • K092998 — CONMED LINVATEC INTERCEPT IMPLANT (December 23, 2009)
  • K091549 — CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM (June 23, 2009)
  • K090835 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR (June 22, 2009)
  • K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES (April 10, 2009)
  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL (February 25, 2009)
  • K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND (May 11, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (April 10, 2006)
  • K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (April 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (March 25, 2005)

Other clearances for product code GCT

  • K093125 — ALPHAXENON LIGHT 180 W AND 300 W (January 27, 2010)
  • K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (December 18, 2008)
  • K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE (August 20, 2007)
  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K022490 — KSEA MEDI PACK (September 29, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (January 14, 2003)
  • K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (August 20, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)
  • K992050 — LUMENON XENON LIGHT SOURCE (September 14, 1999)

FDA data resources