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510(k) K864383

LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS by Luxtec Corp. — Product Code EQH

K864383 is an FDA 510(k) premarket notification submitted by Luxtec Corp. for the device "LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS". The FDA issued a decision of Substantially Equivalent on January 14, 1987. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Luxtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1987
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Luxtec Corp.

  • K973193 — LUXSCOPE (November 21, 1997)
  • K970642 — TENOSCOPE (May 21, 1997)
  • K970562 — TENOSNARE (May 14, 1997)
  • K950960 — REDDY ILLUMINATOR (September 8, 1995)
  • K895248 — IMS5000 ILLUMINATED LOUPES (September 15, 1989)
  • K890716 — LUXTEC ACO SERIES 4000 LIGHT SOURCE (April 26, 1989)
  • K864387 — LUXTEC FIBEROPTIC CABLES (May 22, 1987)
  • K864382 — FRAZIER SUCTION TUBE (January 14, 1987)
  • K864385 — LUXTEC LIGHT SOURCES (January 13, 1987)
  • K864865 — SPECULUM, VAGINAL, METAL FIBEROPTIC (January 9, 1987)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)

FDA data resources