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510(k) K864865

SPECULUM, VAGINAL, METAL FIBEROPTIC by Luxtec Corp. — Product Code HDG

K864865 is an FDA 510(k) premarket notification submitted by Luxtec Corp. for the device "SPECULUM, VAGINAL, METAL FIBEROPTIC". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code HDG (Speculum, Vaginal, Metal, Fiberoptic), a Class I device regulated under 21 CFR 884.4520. Luxtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
December 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Metal, Fiberoptic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
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)
  • K864383 — LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (January 14, 1987)
  • K864382 — FRAZIER SUCTION TUBE (January 14, 1987)
  • K864385 — LUXTEC LIGHT SOURCES (January 13, 1987)

Other clearances for product code HDG

  • K771181 — VAGINAL ILLUMINATOR, MODEL 78570 (July 14, 1977)

FDA data resources